Fluvoxamine Maleate

OSAKA, Japan, September 3, 2025 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) from Shionogi Inc., a New Jersey-based subsidiary of Shionogi, for ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622), an investigational oral antiviral for the prevention of COVID-19 following exposure to an infected individual. The FDA has set an action date of June 16, 2026 under the Prescription Drug User Fee Act (PDUFA). The NDA is supported by results from the global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, which studied ensitrelvir as post-exposure prophylaxis (PEP). If approved, ensitrelvir would be the first and only oral therapy for the prevention of COVID-19 following exposure to an infected individual.1,2 SARS-CoV-2 remains highly transmissible and up to half of people living with an infected individual may develop COVID-19.3,4 The virus is constantly evolving, with novel symptoms reported.5,6 COVID-19 continues to impact daily life and may lead to absences from school and work, may cause long COVID, and in some cases, may progress to severe disease.7-12 Even patients with mild COVID-19 may experience worsening of preexisting chronic conditions.13-17 Following exposure to COVID-19, the best way to avoid its potentially serious and long-term complications is to stop viral replication, which prevents the development of the disease.1,2 There are currently no approved antiviral therapies proven to prevent COVID-19 following exposure.1,2,18 COVID-19 vaccines are received before exposure, and they do not stop viral replication.19,20 Other COVID-19 antivirals are taken following exposure and diagnosis, after viral replication has occurred and disease is already established.21 “Shionogi has a long history of innovation in infectious disease treatment and prevention. Our dedication to this field has led to significant breakthroughs in the development of novel antimicrobials and antivirals for HIV/AIDS, influenza and COVID-19. If approved, ensitrelvir will be the first and only oral therapy to help protect people in the U.S. from COVID-19 following exposure," said Nathan McCutcheon, MBA, President and CEO, Shionogi Inc. About ensitrelvir Ensitrelvir is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease (3-CL), which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. Ensitrelvir, known as Xocova® in countries where it is approved, received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19 based on results from SCORPIO-SR, a Phase 3 study conducted in Asia, during the Omicron-dominant phase of the pandemic. In SCORPIO-SR, ensitrelvir showed both clinical symptomatic efficacy (symptom resolution sustained for at least 24 hours) for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in a predominantly vaccinated population of patients with mild-to-moderate SARS-CoV-2 infection, regardless of risk factors. Most adverse events were mild in severity and no deaths were seen in the study. Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies. Results from this study were published in JAMA Network Open. In 2025, Shionogi submitted two new drug applications in Japan for post-exposure prophylaxis of COVID-19 and for COVID-19 treatment in pediatric patients aged six to under 12 years. The pediatric submission is based on a multicenter, randomized, double-blind, placebo-controlled trial of ensitrelvir in mild-to-moderate COVID-19 patients aged 6 to 12 years in Japan. The study confirmed safety and tolerability and found the pharmacokinetics of ensitrelvir in this age group to be similar to that in adults. Ensitrelvir became available in Singapore for the treatment of COVID-19 via a Special Access Route application in 2023, and it is currently under regulatory review in Taiwan for the treatment of COVID-19. Ensitrelvir is also under regulatory review with the European Medicines Agency for COVID-19 post-exposure prophylaxis and treatment.22 Ensitrelvir is an investigational drug outside of Japan and Singapore. In addition, the brand name Xocova® has not been approved for use outside of Japan and Singapore and pertains only to the approved drug in Japan and Singapore. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html U.S. Media: ShionogiCommunications@shionogi.com SEU Press Office: pressoffice@shionogi.eu * Literature search conducted May 2025. Reference List: 1. US Food and Drug Administration. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19. 2. U.S. Food and Drug Administration. Available at: https://www.fda.gov/search?s=COVID%20post%20exposure%20prophylaxis&sort_bef_combine=rel_DESC&f%5B0%5D=section%3A23692. 3. Baker JM, Nakayama JY, O’Hegarty M, McGowan A, Teran RA, et al. (2025) Household transmission of SARS-CoV-2 in five US jurisdictions: Comparison of Delta and Omicron variants. PLoS One. 2025 Jan 9;20(1):e0313680. DOI:10.1371/journal.pone.0313680. eCollection 2025. 4. Madewell ZJ, Yang Y, Longini IM Jr, Halloran ME, Dean NE. Household Secondary Attack Rates of SARS-CoV-2 by Variant and Vaccination Status: An Updated Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Apr 1;5(4):e229317. DOI:10.1001/jamanetworkopen.2022.9317. 5. Auwaerter P. Coronavirus COVID-19 (SARS-CoV-2). Johns Hopkins ABX Guide. Updated 2024. Accessed August 7, 2025. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540747/all/Coronavirus_COVID_19__SARS_CoV_2_. 6. Centers for Disease Control and Prevention. Symptoms of COVID-19. Updated March 15, 2024. Accessed August 7, 2025. https://www-cdc-gov.libproxy1.nus.edu.sg/coronavirus/2019-ncov/symptoms-testing/symptoms.html. 7. Xu F, Brodszky V. The impact of COVID-19 on health-related quality of life: a systematic review and evidence-based recommendations. Discover Psychology. 2 Aug 2024;4(90). DOI:10.1007/s44202-024-00204-8. 8. Centers for Disease Control and Prevention. Long Covid Basics. Accessed August 5, 2025. Available at: https://www-cdc-gov.libproxy1.nus.edu.sg/covid/long-term-effects/index.html. 9. Judy J, Yehoshua A, Gouveia-Pisano J, et al. Impact of COVID-19 on work loss in the United States- A retrospective database analysis. J Med Econ. 2024 Jan-Dec;27(1):941-951. DOI:10.1080/13696998.2024.2379056. Epub 2024 Jul 18. PMID: 38984895. 10. Student-level attendance patterns show depth, breadth, and persistence of post-pandemic absenteeism. Brookings.edu. Accessed August 5, 2025. Available at https://www.brookings.edu/articles/student-level-attendance-patterns-show-depth-breadth-and-persistence-of-post-pandemic-absenteeism/. 11. Chronic Absenteeism. U.S. Department of Education. Accessed August 5, 2025. Available at https://www.ed.gov/teaching-and-administration/supporting-students/chronic-absenteeism. 12. Dee TS. Higher Chronic Absenteeism Threatens Academic Recovery from the COVID-19 Pandemic. Proc Natl Acad Sci U S A. 2024 Jan 16;121(3):e2312249121. DOI:10.1073/pnas.2312249121. 13. Xie Y, Xu E, Bowe B, Al-Aly Z. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022 Feb 7;28(3):583-590. DOI:10.1038/s41591-022-01689-3. 14. Xie Y, Xu E, Al-Aly Z. Risks of mental health outcomes in people with covid-19: cohort study. BMJ. 2022 Feb 16:376:e068993. DOI:10.1136/bmj-2021-068993. 15. Srivastava S, Garg I. Post COVID-19 infection: Long-term effects on liver and kidneys. World J Meta-Anal 2021; 9(3): 220-233 DOI:10.13105/wjma.v9.i3.220. 16. Tenforde M, Kim S, Lindsell C, et al. Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network - United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020 Jul 31;69(30):993-998. DOI:10.15585/mmwr.mm6930e1. 17. Graham E, Clark J, Orban Z, et al. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized Covid-19 "long haulers". Ann Clin Transl Neurol. 2021 May;8(5):1073-1085. DOI:10.1002/acn3.51350. Epub 2021 Mar 30. 18. Focosi D, Franchini M, Maggi F, Shoham S. COVID-19 therapeutics. Clinical microbiology reviews. 2024 Jun 13;37(2):e00119-23. DOI: 10.1128/cmr.00119-23. 19. Thompson MG, Burgess JL, et al. Prevention and attenuation of Covid-19 with the BNT162b2 and mRNA-1273 vaccines. New England Journal of Medicine. 2021 Jul 22;385(4):320-9. DOI:10.1056/NEJMoa2107058. 20. Park HJ, Gonsalves GS, Tan ST, et al. Comparing frequency of booster vaccination to prevent severe COVID-19 by risk group in the United States. Nature Communications. 2024 Mar 6;15(1):1883. DOI: 10.1038/s41467-024-45549-9. 21. Wen W, et al. Efficacy and safety of three new oral antiviral treatment (molnupiravir, fluvoxamine and Paxlovid) for COVID-19 a meta-analysis. Ann Med. 2022 Feb 4;54(1):516–523. DOI:10.1080/07853890.2022.2034936. 1st Quarter of Fiscal 2025 Financial Results. July 28, 2025. Accessed August 25, 2025. Available at https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2025/1q/E_FY2025_Q1_final.pdf

26 scientific abstracts, including two oral presentations, demonstrate UCB's ongoing commitment to advancing research for people living with epilepsies Data include an open-label extension study describing the long-term safety of FINTEPLA®▼ (fenfluramine)[1] and global functioning in children and adults with Dravet syndrome or Lennox-Gastaut syndrome[2] Data provide insights on developmental and epileptic encephalopathies (DEEs), including a qualitative study addressing diagnostic challenges and benefits in adult care settings, and a caregiver survey exploring the daily impacts of unpredictable seizures and disruptive behaviors[3],[4] Additional focus on defining prolonged seizures and their real-world impact on patients and caregivers[5],[6],[7] BRUSSELS, Aug. 29, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced it will present 26 abstracts from its epilepsy portfolio at the International Epilepsy Congress (IEC) Congress, Lisbon, Portugal, August 30 – September 3, 2025. Data will focus on developmental and epileptic encephalopathies (DEEs), such as Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), as well as prolonged seizures, seizure emergencies and early pipeline research. Dimitrios Bourikas, Global Medical Head of DEE and Epilepsy , UCB, commented: "At UCB, we are committed to driving improvements in all aspects of care for people living with epilepsies and severe epileptic conditions. The breadth of data we are presenting at the International Epilepsy Congress reflects our dedication to advancing innovative solutions that address real-world patient needs. By deepening insights into disease mechanisms, treatment outcomes, and the experiences of both patients and caregivers, we strive to shape a better future for those affected by epileptic conditions." Highlights of data to be presented at IEC : Fenfluramine: A combined open-label extension (OLE) study enrolled 412 patients with DS or LGS who had participated in three previous fenfluramine studies, reporting no new or unexpected safety signals and long-term sustained benefit.[2] Barriers and benefits of identifying patients with DEEs in adult care settings: Although the diagnosis of DEEs in children has become routine, significant diagnostic gaps remain for adults. This qualitative study, based on interviews with caregivers and healthcare professionals in the UK, Germany, France, and Spain, found that a confirmed diagnosis fosters holistic care, which may improve quality of life (QoL), enhance communication and reduce risk of hospitalization for patients.[4] Unpredictable seizures and disruptive behavior in DEEs: Interim results of a caregiver survey: An internet-based anonymous 63-question survey was distributed to caregivers of patients with DEEs by multiple DEE-specific patient groups. Nearly half of caregivers reported that high rates of disruptive seizures/behavior led to temporary loss in abilities, previously associated with reduced quality of life.[3] Prolonged seizures: Research characterizing patient and caregiver experiences of prolonged seizures describes unmet needs and the significant short-term and long-term negative impact on quality of life.[7] Real-world data from Adelphi's Prolonged Seizure Disease Specific Programme™ characterizes the definition, prevalence, and patient population of prolonged seizures finding that people living with epilepsy experiencing prolonged seizures encounter significant seizure worry due to their seizure. In addition, these seizures regularly progress to status epilepticus and/or seizure clusters, leading to emergency care and hospital admissions, despite best practice.[5] A post hoc analysis of video-EEG recordings from 725 patients explores seizure duration and time-point cutoffs for statistically defining possible and probable prolonged seizures by seizure type, supporting the 2-minute cutoff for tonic-clonic seizures (focal/generalized onset) and suggesting a 1 to 3 minutes cutoff for other seizures, confirming that most seizure are abnormally prolonged at 2 minutes or less[6] Seizure pathways: A qualitative study aimed to understand the end-to-end care process for acute seizure emergencies finding that a stronger focus on outpatient guidelines could empower patients and caregivers to manage prolonged seizures in the outpatient setting, potentially avoiding unnecessary seizure escalation, injury, hospitalization and death.[8] Acute medication landscape: A global analysis assessed the availability and reimbursement coverage of seizure acute medications for use in the outpatient setting.[9] Lennox-Gastaut syndrome: Diagnosing LGS is challenging due to the heterogeneity of its clinical presentation and symptom evolution over time. A group of ten epilepsy experts from seven countries convened to develop a simple-to-use checklist for non-specialists to support LGS diagnosis, using the International League Against Epilepsy criteria as a framework.[10] UCB-sponsored symposium: Time matters in developmental and epileptic encephalopathies Date: Monday, September 1st, 13:55 – 15:05 Overview: The upcoming symposium aims to enhance knowledge and awareness of the broader impact of DEEs in adulthood - beyond seizure control. The session will focus on improving diagnosis, understanding treatment journeys and addressing barriers to care in order to drive better individual outcomes. UCB presentations during the International Epilepsy Congress (IEC) Congress Annual Meeting About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. Important Safety Information about FINTEPLA▼ (fenfluramine) in the EU[1] Indications: Treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older. Dosage and Administration: Please refer to SmPC for full information. Should be initiated and supervised by physicians with experience in the treatment of epilepsy. Fintepla is prescribed and dispensed according to the Fintepla controlled access programme. Dravet syndrome: Patients who are not taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day). After an additional 7 days, if tolerated and further seizure reduction required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose. Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day), which is the recommended maintenance dose. Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed a total dose of 17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increased to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated. After an additional 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When discontinuing treatment, decrease the dose gradually. As with all anti-epileptic medicines, avoid abrupt discontinuation when possible to minimize the risk of increased seizure frequency and status epilepticus. A final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. Renal impairment: Generally, no dose adjustment is recommended when administered to patients with mild to severe renal impairment, however, a slower titration may be considered. If adverse reactions are reported, a dose reduction may be needed. Has not been studied in patients with end-stage renal disease. Not known if fenfluramine or its active metabolite, norfenfluramine, is dialyzable. Hepatic impairment: Hepatic impairment: Generally, no dose adjustment is recommended when Fintepla is administered without concomitant stiripentol to patients with mild and moderate hepatic impairment (Child-Pugh Class A and B). In patients with severe hepatic impairment (Child-Pugh C) not receiving concomitant stiripentol, the maximum dosage is 0.2mg/kg twice daily, and the maximal total daily dose is 17 mg. There are limited clinical data on the use of Fintepla with stiripentol in patients with mild impaired hepatic function. A slower titration may be considered in patients with hepatic impairment and a dose reduction may be needed if adverse reactions are reported. No clinical data is available on the use of Fintepla with stiripentol in moderate and severe hepatic impairment, therefore not recommended for use. Elderly: No data available. Paediatric population: Safety and efficacy in children below 2 years of age not yet established. No data available. Contraindications: Hypersensitivity to active substance or any excipients. Aortic or mitral valvular heart disease and pulmonary arterial hypertension. Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome. Warnings and Precautions: Aortic or mitral valvular heart disease and pulmonary arterial hypertension: Prior to starting treatment, patients must undergo an echocardiogram to establish a baseline and exclude any pre-existing valvular heart disease or pulmonary hypertension. Conduct echocardiogram monitoring every 6 months for the first 2 years and annually thereafter. If an echocardiogram indicates pathological valvular changes, consider follow-up earlier to evaluate whether the abnormality is persistent. If pathological abnormalities seen on echocardiogram, evaluate the benefit versus risk of continuing fenfluramine treatment with the prescriber, caregiver and cardiologist. Once treatment is discontinued for any reasons, a final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. If echocardiogram findings suggestive of pulmonary arterial hypertension, perform a repeat echocardiogram as soon as possible and within 3 months to confirm these findings. If echocardiogram finding is confirmed suggestive of an increased probability of pulmonary arterial hypertension defined as intermediate probability, conduct a benefit-risk evaluation of continuation of Fintepla by the prescriber, carer and cardiologist. If echocardiogram suggests a high probability, it is recommended fenfluramine treatment should be stopped. Decreased appetite and weight loss: Fenfluramine can cause decreased appetite and weight loss - an additive effect can occur in combination with other anti-epileptic medicines such as stiripentol. Monitor the patient's weight. Undertake risk-benefit evaluation before starting treatment if history of anorexia nervosa or bulimia nervosa. Fintepla controlled access programme: A controlled access programme has been created to 1) prevent off-label use in weight management in obese patients and 2) confirm that prescribing physicians have been informed of the need for periodic cardiac monitoring in patients taking Fintepla. Somnolence: Fenfluramine can cause somnolence which could be potentiated by other central nervous system depressants. Suicidal behaviour and ideation: Suicidal behaviour and ideation have been reported in patients treated with anti-epileptic medicines in several indications. Advise patients and caregivers to seek medical advice should any signs of suicidal behaviour and ideation emerge. Serotonin syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with fenfluramine treatment, particularly with concomitant use of other serotonergic agents; with agents that impair metabolism of serotonin such as MAOIs; or with antipsychotics that may affect the serotonergic neurotransmitter systems. Carefully observe the patient, particularly during treatment initiation and dose increases. Increased seizure frequency: A clinically relevant increase in seizure frequency may occur during treatment, which may require adjustment in the dose of fenfluramine and/or concomitant anti-epileptic medicines, or discontinuation of fenfluramine, should the benefit-risk be negative. Cyproheptadine: Cyproheptadine is a potent serotonin receptor antagonist and may therefore decrease the efficacy of fenfluramine. If cyproheptadine is added to treatment with fenfluramine, monitor patient for worsening of seizures. If fenfluramine treatment is initiated in a patient taking cyproheptadine, fenfluramine's efficacy may be reduced. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Discontinue therapy in patients with acute decreases in visual acuity. Consider discontinuation if ocular pain of unknown origin. Effect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 inducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations, which may lower the efficacy of fenfluramine. If co-administration is considered necessary, the patient should be monitored for reduced efficacy and a dose increase of fenfluramine could be considered provided that it does not exceed twice the maximum daily dose (52 mg/day). If a strong CYP1A2 or CYP2B6 inducer is discontinued during maintenance treatment with fenfluramine, consider gradual reduction of the fenfluramine dosage to the dose administered prior to initiating the inducer. Effect of CYP1A2 or CYP2D6 inhibitors: Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure and, therefore, adverse events should be monitored, and a dose reduction may be needed in some patients. Excipients: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl para-hydroxybenzoate (E 219) - may cause allergic reactions (possibly delayed). It also contains sulfur dioxide (E 220) which may rarely cause severe hypersensitivity reactions and bronchospasm. Patients with rare glucose-galactose malabsorption should not take this medicine. The product contains less than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially 'sodium-free'. Contains glucose - may be harmful to teeth. Interactions: Pharmacodynamic interactions with other CNS depressants increase the risk of aggravated central nervous system depression. An increase in dose may be necessary when coadministered with rifampicin or a strong CYP1A2 or CYP2B6 inducer. In in vitro studies coadministration with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 of the SmPC). Coadministration with CYP2D6 substrates or MATE1 substrates may increase their plasma concentrations. Co-administration with CYP2B6 or CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and lactation: Limited data in pregnant women. As a precaution, avoid use of Fintepla in pregnancy. It is unknown whether fenfluramine/metabolites are excreted in human milk. Animal data have shown excretion of fenfluramine/metabolites in milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fintepla taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Drive and use machines.: Fintepla has moderate influence on the ability to drive/ use machines as it may cause somnolence and fatigue. Advise patients not to drive or operate machinery until they have sufficient experience to gauge whether it adversely affects their abilities. Adverse effects: Dravet syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of trace and mild mitral regurgitation, and trace aortic regurgitation, which are considered physiologic). Common (≥1/100 to <1/10): Bronchitis, abnormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypotonia, lethargy, seizure, status epilepticus, tremor, constipation, salivary hypersecretion, weight decreased and blood prolactin increased. Lennox-Gastaut syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fatigue. Common (≥1/100 to <1/10): Bronchitis, influenza, pneumonia, seizure, status epilepticus, lethargy, tremor, constipation, salivary hypersecretion, blood prolactin increased, weight decreased, fall. Refer to SmPC for other adverse reactions. ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information: . FINTEPLA® is a registered trademark of the UCB Group of Companies. Important Safety Information about BRIVIACT® (brivaracetam) in the EU[28] Therapeutic indications: BRIVIACT is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Posology and method of administration: The physician should prescribe the most appropriate formulation and strength according to weight and dose. It is recommended to parent and care giver to administer BRIVIACT oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box. BRIVIACT solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible. There is no experience with twice daily intravenous administration of brivaracetam for a period longer than 4 days. Adults: The recommended starting dose is 50 or 100 mg/day based on physician's assessment of required for seizure reduction versus potential side effects. Brivaracetam can be taken with or without food. Based on individual patient response and tolerability, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day. Children and adolescents weighing 50 kg or more: The recommended starting dose is 50 mg/day. Brivaracetam may also be initiated at 100 mg/day based on physician's assessment of need for seizure control. The recommended maintenance dose is 100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day. Children and adolescents weighing from 20 kg to less than 50 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2 mg/kg/day based on physician's assessment of need for seizure control. The recommended maintenance dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day. Children weighing from 10 kg to less than 20 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2.5 mg/kg/day based on physician's assessment of need for seizure control. The recommended maintenance dose is 2.5 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 5 mg/kg/day. For adults, adolescents and children from 2 years of age, the dose should be administered in two equally divided doses, approximately 12 hours apart. If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. Brivaracetam oral solution can be diluted in water or juice shortly before swallowing; a nasogastric tube or a gastrostomy tube may also be used. Brivaracetam may be initiated with either intravenous or oral administration. When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained. Brivaracetam may be administered as an intravenous bolus without dilution or diluted in a compatible diluent and administered as a 15-minute intravenous infusion. This medicinal product must not be mixed with other medicinal products. Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions, e.g. status epilepticus, and is therefore not recommended for such conditions. For patients from 16 years of age, if brivaracetam has to be discontinued, it is recommended that the dose is reduced gradually by 50 mg/day on a weekly basis. For patients below the age of 16 years, if brivaracetam has to be discontinued, it is recommended that the dose is reduced by a maximum of half the dose every week until a dose of 1 mg/kg/day (for patients with a body weight less than 50 kg) or 50 mg/day (for patients with body weight of 50 kg or more) is reached. After 1 week of treatment at 50 mg/day, a final week of treatment at 20 mg/day is recommended. No dose adjustment is needed for elderly patients (≥65 years of age) or for those with renal impairment. Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function. No clinical data are available on paediatric patients with renal impairment. Brivaracetam is not recommended for patients with end-stage renal disease undergoing dialysis due to lack of data. Exposure to brivaracetam was increased in patients with chronic liver disease. In patients with hepatic impairment, the following adjusted doses, administered in 2 divided doses, approximately 12 hours apart, are recommended for all stages of hepatic impairment: In adults, adolescents and children weighing ≥50 kg, a 50 mg/day starting dose is recommended, with a maximum daily dose of 150 mg/day. For adolescents and children weighing from 20 kg to <50 kg, a 1 mg/kg/day is recommended, with a maximum daily dose of 3 mg/kg/day. For children weighing from 10 kg to <20 kg, a 1 mg/kg/day is recommended, with a maximum daily dose of 4 mg/kg/day. No clinical data are available in paediatric patients with hepatic impairment. The efficacy of brivaracetam in paediatric patients aged less than 2 years has not yet been established. Contraindications: Hypersensitivity to the active substance, other pyrrolidone derivatives or any of the excipients. Special warnings and precautions for use: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs) in several indications, including brivaracetam. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge. Clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment are limited. Dose adjustments are recommended for patients with hepatic impairment. Brivaracetam film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take brivaracetam. Brivaracetam film-coated tablets, solution for injection/infusion and oral solution contain less than 1 mmol sodium (23mg) per tablet/vial/ml respectively, that is to say essentially 'sodium free'. Brivaracetam oral solution contains 168 mg sorbitol (E420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Brivaracetam oral solution contains propylene glycol (E1520). Interaction with other medicinal products and other forms of interaction: In clinical studies, although patient numbers were limited, brivaracetam had no observed benefit over placebo among patients taking concomitant levetiracetam. No additional safety or tolerability concern was observed. In an interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy volunteers, there was no pharmacokinetic interaction, but the effect of alcohol on psychomotor function, attention and memory was approximately doubled with the intake of brivaracetam. Intake of brivaracetam with alcohol is not recommended. In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway of brivaracetam® is by CYPindependent hydrolysis; a second pathway involves hydroxylation mediated by CYP2C19. Brivaracetam plasma concentrations may increase when co-administered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19 mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain. In healthy subjects, co-administration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45%. Prescribers should consider adjusting the dose of brivaracetam in patients starting or ending treatment with rifampicin. Brivaracetam plasma concentrations are decreased when co-administered with strong enzyme-inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required. Other strong enzyme inducers such as St John's wort (Hypericum perforatum) may decrease the systemic exposure of brivaracetam. Starting or ending treatment with St John's wort should be done with caution. Brivaracetam at 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4). The risk of clinically relevant CYP3A4 interactions is considered low. In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19 and may therefore increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, omeprazole, diazepam). Brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6 in vitro. No CYP3A4 induction was found in vivo. CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3. In vitro, brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose. Brivaracetam 200 mg/day may increase plasma concentrations of medicinal products transported by OAT3. Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase, resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine. In controlled clinical studies, carbamazepine epoxide plasma concentration increased by a mean of 37%, 62% and 98% with little variability at Brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day, respectively. No safety risks were observed. There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide. No dose adjustment is needed when brivaracetam is co-administered with carbamazepine, phenobarbital or phenytoin. Brivaracetam had no clinically relevant effect on the plasma concentrations of clobazam, clonazepam, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, pregabalin, topiramate, valproic acid or zonisamide. There are no data available on the effects of clobazam, clonazepam, lacosamide, pregabalin or zonisamide on brivaracetam plasma concentrations. Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. However, when brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose), a reduction in estrogen and progestin AUCs of 27% and 23%, respectively, was observed without impact on suppression of ovulation. Pregnancy: Data on the use of brivaracetam in pregnant women are limited. There are no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats. The potential risk for humans is unknown. Animal studies did not detect any teratogenic potential of brivaracetam. In clinical studies, adjunctive brivaracetam used concomitantly with carbamazepine induced a dose-related increase in the concentration of the active metabolite, carbamazepine-epoxide. There are insufficient data to determine the clinical significance of this effect in pregnancy. Brivaracetam should not be used during pregnancy unless clinically necessary. Breast-feeding: Brivaracetam is excreted in human breast milk. The decision to discontinue either breastfeeding or brivaracetam should be made based on the benefit of the medicinal product to the mother. In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase. The clinical significance remains unknown. Fertility: No human data on the effect of brivaracetam on fertility are available. There was no effect on fertility in rats. Effects on ability to drive and use machines: Brivaracetam has minor or moderate influence on the ability to drive and use machines. Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities. Undesirable effects: The most frequently reported adverse reactions with brivaracetam were somnolence (14.3%) and dizziness (11.0%); they were usually mild-to-moderate in intensity. Somnolence and fatigue were reported at a higher incidence with increasing dose. Very common adverse reactions (≥1%-<10%) were influenza, decreased appetite, depression, anxiety, insomnia, irritability, convulsion, vertigo, upper respiratory tract infections, cough, nausea, vomiting, constipation and fatigue. Neutropenia was reported in 6/1099 (0.5%) of brivaracetam and none (0/459) of the placebo-treated patients. Four of these subjects had decreased neutrophil counts at baseline. None of the neutropenia cases were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections. Suicidal ideation was reported in 0.3% (3/1099) of brivaracetam and 0.7% (3/459) of placebo-treated patients. In short-term clinical studies of brivaracetam in patients with epilepsy, there were no cases of completed suicide and suicide attempt; however, both were reported in open-label extension studies. The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (assessed from 6 years onwards, more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults. The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7 %). No specific pattern of adverse event (AE) was identified in children from 1 month to < 4 years of age when compared to older paediatric age groups. No significant safety information was identified indicating the increasing incidence of a particular AE in this age group. As data available in children younger than 2 years of age are limited, brivaracetam is not indicated in this age range. Limited clinical data are available in neonates. Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development. Overdose: There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam. The following adverse reactions were reported with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation in the postmarketing experience. In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions. There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include general supportive measures. Since <10% of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance. Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information: BRIVIACT® is a registered trademark of the UCB Group of Companies. References: 1. Fintepla® EU SmPC. Available at:. Accessed: July 2025. 2. Schoonjans A, et al. Tolerability and Safety of Fenfluramine and Global Functioning of Patients in a Combined Open-label Extension Study of Children and Adults With Dravet and Lennox-Gastaut Syndromes. IEC. 2025. Abstract number: 921. 3. Wilkinson AL, et al. Unpredictable Seizures and Disruptive Behavior in Developmental and Epileptic Encephalopathies: Interim Results of a Caregiver Survey. IEC. 2025. Abstract number: 1389. 4. Rodriguez Solis B, et al. Barriers and benefits of identifying patients with DEE in adult care settings. IEC. 2025. Abstract number: 2009. 5. Trinka E, et al. Describing the Population of Patients with Prolonged Seizures: Results from a Global Real-World Point In-Time Study. IEC. 2025. Abstract number: 711. 6. Sile B, et al. Seizure Duration and Time-point Cutoffs for Statistically Defining a Prolonged Seizure: A Post-Hoc Analysis of the SCORE Video-EEG Database. IEC. 2025. Abstract number: 712. 7. Kaye D, et al. Characterising Patient and Caregiver Experiences Resulting from Prolonged Seizures. IEC. 2025. Abstract number: 625. 8. Sain N, et al. Understanding and Optimising the Seizure Emergency Pathway. IEC. 2025. Abstract number: 630. 9. Shafer P, et al. Global Seizure Rescue Medication Landscape: Availability & Reimbursement. IEC. 2025. Abstract number: 628. 10. Specchio N, et al. A checklist to support the diagnosis of Lennox-Gastaut syndrome. IEC. 2025. Abstract number: 1926. 11. Soto Insuga V, et al. Improving Lives in Dravet Syndrome: Overcoming Challenges in the Family Journey. IEC. 2025. Abstract number: 1063. 12. Lothe A, et al. A Retrospective Claims Study Evaluating Mortality in Patients With Lennox-Gastaut or Dravet Syndromes in the United States. IEC. 2025. Abstract number: 912. 13. Montero V, et al. Lennox-Gastaut Syndrome. Situation analysis and Family Journey. IEC. 2025. Abstract number: 1071. 14. Nabbout R, et al. Impact of Fenfluramine on Convulsive Seizure Frequency in Dose-Capped Patients With Dravet Syndrome. IEC. 2025. Abstract number: 926. 15. Lagae L, et al. A Stratified Analysis of Efficacy and Safety of Fenfluramine in Patients With Dravet Syndrome. IEC. 2025. Abstract number: 917. 16. Wirrell E, et al. Real-World Use of Fenfluramine for Dravet Syndrome: a Retrospective Cohort Study Using a National Pharmacy Database. IEC. 2025. Abstract number: 1112. 17. Gjerulfsen CE, et al. Non-seizure benefits of long-term fenfluramine treatment in pediatric patients with Dravet syndrome. IEC. 2025. Abstract number: 955. 18. Rosendahl A, et al. Prospective evaluation of non-seizure benefits related to treatment with fenfluramine in pediatric and adult patients with Dravet syndrome. IEC. 2025. Abstract number: 957. 19. Lothe A, et al. A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine Oral Solution in Dravet Syndrome and Lennox-Gastaut Syndrome. IEC. 2025. Abstract number: 1389. 20. Dransfeld CR, et al. Use of Fenfluramine and Cannabidiol in Daily Practice: A Retrospective Analysis of German Prescription Claims. IEC. 2025. Abstract number: 312. 21. Mittur A, et al. Exposure-Response Relationships of Fenfluramine in Patients With Dravet Syndrome and Lennox-Gastaut Syndrome. IEC. 2025. Abstract number: 1983. 22. Zuberi S, et al. Post-hoc Analysis of Fenfluramine for Lennox-Gastaut Syndrome by Baseline Frequency Quartiles of Seizures Associated With a Fall. IEC. 2025. Abstract number: 911. 23. Rodriguez N, et al. AAV gene therapy at neonatal age in a mouse model of STXBP1 haploinsufficiency. IEC. 2025. Poster number: 226. 24. Gomes AR, et al. Rescue of neuronal activity in iPSC-derived STXBP1 in vitro disease models using viral vectors. IEC. 2025. Poster number: 936. 25. Niespodziany I, et al. In vitro electrophysiological study of hippocampal network activity in a mouse model of STXBP1 haploinsufficiency. IEC. 2025. Poster number: 841. 26. Herrewegen YVD, et al. Expression and quantification of STXBP1 splice variants in rodent and primate brain tissues. IEC. 2025. Poster number: 996. 27. Briviact® EU SmPC. Available at:. Accessed: July 2025. 28. Zafeiriou D, et al. Brivaracetam Adjunctive Therapy in Paediatric and Adult Patients With Focal-Onset Seizures in Mid-European Countries: 12-Month, Real-World Outcomes from the BRIVA-REG Study. IEC. 2025. Poster number: 708. Logo: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED