来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
Free ReportHow is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.
来源: Pharmaceutical Technology
Antigua & Barbuda (+1268)
Bosnia Herzegovina (+387)
Cape Verde Islands (+238)
Central African Republic (+236)
Dominican Republic (+1809)
Sao Tome & Principe (+239)
Trinidad & Tobago (+1868)
Turks & Caicos Islands (+1649)
United Arab Emirates (+971)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Bonaire, Sint Eustatius and Saba
British Indian Ocean Territory
French Southern Territories
Heard Island and McDonald Islands
Saint Helena, Ascension and Tristan da Cunha
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
South Georgia and The South
US Minor Outlying Islands
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The FDA previously granted the drug accelerated approval as the first therapy for the treatment of IgAN, in December 2021. The agency has now set a prescription drug user fee act (PDUFA) date for this supplemental new drug application (sNDA) application of 20 December 2023. 来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
The FDA accepted Calliditas’s sNDA for the drug based on the full data set from the Phase III NefIgArd clinical study (NCT03643965). Patients treated for nine months with Tarpeyo showed a significant reduction of approximately 30%, in the urine protein-to-creatinine ratio compared with the placebo group. The trial also met its primary endpoint of estimated glomerular filtration rate (eGFR), as the therapy demonstrated a significant kidney protective effect over the placebo.
Tarpeyo is an oral glucocorticoid anti-inflammatory agent that suppresses the gut immune system. This allows the drug to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. The drug was previously being developed under the brand name Nefecon, with the company renaming the novel targeted-release formulation of the drug as Tarpeyo. This formulation comprises a 4mg enteric-coated capsule, designed to remain intact until it reaches the patient’s ileum. In the 18 August press release announcing the priority review, Calliditas’ CEO Renee Aguiar-Lucander said: “The significant eGFR treatment benefit observed across the entire study population provides further evidence that TARPEYO can be disease-modifying, potentially significantly delaying the need for dialysis or kidney transplantation for patients at risk.” IgAN is a kidney disorder caused by a build-up of antibodies in the kidney tissue. This can cause the kidneys to gradually fail, requiring some patients to undergo dialysis, or in severe cases, kidney transplants. The condition mostly develops between the late teens and late 30s. Calliditas is also working with its European partner, STADA Arzneimettel, to push a European Commission approval of the drug under the brand name Kinpeygo, following its 2022 European conditional authorisation. The Sweden-headquartered company also received conditional approval for the treatment from the UK’s Medicines and healthcare products regulatory agency (MHRA) in February 2023. Free ReportHow is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.By GlobalData
来源: Pharmaceutical Technology
Antigua & Barbuda (+1268)
Bosnia Herzegovina (+387)
Cape Verde Islands (+238)
Central African Republic (+236)
Dominican Republic (+1809)
Sao Tome & Principe (+239)
Trinidad & Tobago (+1868)
Turks & Caicos Islands (+1649)
United Arab Emirates (+971)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Bonaire, Sint Eustatius and Saba
British Indian Ocean Territory
French Southern Territories
Heard Island and McDonald Islands
Saint Helena, Ascension and Tristan da Cunha
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
South Georgia and The South
US Minor Outlying Islands
-->By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit
Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
Thank you.Please check your email to download the Report.