Deutetrabenazine

全球药物批准/研发动态 01 全球新药批准情况 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）全球（不含中国）共有7个新药获批上市。其中，NDA批准1个，BLA批准3个，新适应症批准1个，新剂型批准2个。与上个统计周期相比，本次增加2个批准新药。 5月29日，TEVA宣布，FDA已批准AUSTEDO XR作为每日一次的单粒治疗选择（现在有四种新的片剂规格：30、36、42、48毫克），适用于成人TD和HD舞蹈病。服用AUSTEDO XR的TD患者最早可以在两周内获得症状改善，而HD舞蹈症患者的TMC评分可能会显著降低。AUSTEDO XR及其每日两次的对应药物AUSTEDO（氘代丁苯那嗪）是唯一一种对CYP3A4/5诱导剂或抑制剂使用没有限制的VMAT2抑制剂治疗药物。 同日，BMY宣布EC已批准奥迪沃®（纳武利尤单抗）联合顺铂和吉西他滨一线治疗不可切除或转移性尿路上皮癌（UC）成人患者。在CheckMate-901试验中，Opdivo与顺铂和吉西他滨的组合提高了总生存期，与单独化疗相比，疾病进展或死亡的风险降低了28%，并且与单独化疗相比，表现出深刻而持久的反应。 全球（不含中国）新药批准情况（部分） 02 全球新药申报进展 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）全球（不含中国）共有12个新药申报上市。其中，NDA申报进展4个，BLA申报进展6个，疫苗2个。与上次统计周期相比，本次增加9个NDA/BLA申报。 5月27日，Sanofi宣布Sarclisa接受FDA优先审评，用于治疗不符合移植条件的新诊断多发性骨髓瘤。Sarclisa是一种单克隆抗体，可与多发性骨髓瘤细胞上CD38受体的特定表位结合，诱导不同的抗肿瘤活性。如果获得批准，Sarclisa将成为第一个与标准护理VRd联合的抗CD38疗法。 NDA/BLA申报 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）全球（不含中国）共有11个物获监管机构特殊资格认定。其中，化学药4个，生物药6，细胞疗法1个。与上次统计周期相比，本次增加3获监管机构特殊资格认定的药物。 5月29日，Alentis宣布FDA已授予Lixudebart（ALE.F02）用于治疗特发性肺纤维化（IPF）的孤儿药认定。Lixudebart是针对肝、肺和肾纤维化开发的首创单克隆抗体。该研究抗体旨在通过特异性靶向暴露于纤维化组织中的独特CLDN1表位来逆转器官纤维化。在I期研究中，Lixudebart耐受性良好。目前，Lixudebart正在临床试验中测试晚期肝纤维化（NCT05939947）和ANCA相关血管炎（NCT06047171）。 5月31日，万邦德制药宣布乙酰胆碱酯酶抑制剂（石杉碱甲）获得FDA授予的治疗新生儿缺氧缺血性脑病（HIE）的孤儿药资格认定。石杉碱甲具有抗炎、抗氧化应激与神经保护等作用，适用于良性记忆障碍，对痴呆患者和脑器质性病变引起的记忆障碍有改善作用，亦用于重症肌无力的治疗。万邦德制药是国内主要的石杉碱甲原料药供应商，同时有石杉碱甲注射液在售，并与中科院上海药物研究所共同开发石杉碱甲控释片，正在开展治疗阿尔茨海默病的患者临床研究。 特殊资格认定情况（部分） 03 全球新药研发进展 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）全球（不含中国）新药临床研发状态更新共计67条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、精神疾病、神经疾病以及皮肤病等共计15个领域。 其中，肿瘤临床进展更新居各领域之首，为26条：肿瘤领域涉及化学药9条，生物药14条，细胞疗法2条，疫苗1条。 5月28日，信达生物宣布重组抗白介素23p19亚基抗体注射液匹康奇拜单抗在中国中重度斑块状银屑病受试者中开展的III期临床研究中达成主要终点和所有关键次要终点。匹康奇拜单抗为重组抗白介素23p19亚基抗体注射液，是一种单克隆抗体，通过阻止IL-23与细胞表面受体结合，阻断IL-23受体介导信号通路发挥抗炎作用。 5月30日，药明巨诺在EULAR2024上公布了瑞基奥仑赛注射液（Relma-cel）在中国成人活动性系统性红斑狼疮患者中的最新临床数据。Relma-cel是靶向CD19的自体CAR-T细胞免疫治疗产品，参与试验的患者均呈现良好的安全性和耐受性，仅出现1例3级CRS，没有出现3级及以上神经毒性，仅2例患者出现3级感染，所有不良事件均能在经过相应治疗后恢复。 全球新药研发进展详情（部分） 04 全球医药交易事件 本次统计周期（2024.05.25-05.31）全球（含中国）医药交易时间共计53起，涉及药物权益转让、公司并购等多起交易事件。 全球医药交易时间汇总表（部分） 国内药物批准/研发动态 01 国内新药批准情况 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）国内共有2个新药获NMPA批准上市。其中，新适应症批准2个。与上次统计周期相比，本次减少9个NMPA批准新药。 5月27日，博安生物宣布地舒单抗注射液（120mg）——博洛加®正式获得NMPA上市批准，用于治疗不可手术切除或者手术切除可能导致严重功能障碍的骨巨细胞瘤，包括成人和骨骼发育成熟（定义为至少1处成熟长骨且体重≥45kg）的青少年患者。同时，博洛加®用于实体肿瘤骨转移和多发性骨髓瘤适应症的上市申请工作也在推进中。此外，博安生物也在欧洲、美国、日本开展博洛加®的国际多中心III期临床试验。 5月28日，琅钰集团宣布NMPA正式批准盐酸替洛利生片（铧可思®）用于治疗发作性睡病（Narcolepsy）青少年和6岁及以上儿童患者的日间过度嗜睡（EDS）或猝倒。这是替洛利生在成人发作性睡病之外，在我国获批的第二个适应症。替洛利生是全球首个成药的选择性组胺3（H3）受体反向激动剂，无成瘾性，单药使用可改善发作性睡病的多个核心症状。替洛利生在EMA和FDA分别获得了孤儿药认定，并被FDA认定为突破性治疗药物。 中国新药批准情况（部分） 02 国内新药临床默示许可进展 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）国内共有17个新药获临床默示许可，涉及27个受理号。其中，化学药9个，治疗用生物制品7个，预防性生物用品1个。与上个统计周期相比，本次减少24个临床默示许可获批受理号。 本周国内新药临床默示许可进展（部分） 03 国内新药申报进展 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）国内共有1个新药申报上市，涉及4个受理号。其中，治疗用生物制品1个。与上个统计周期相比，本次减少4个新药申报上市受理号。 国内新药申报上市情况 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）国内共有35个新药申报临床，涉及53个受理号。其中，化学药16个，治疗用生物制品18个，预防用生物制品1个。与上个统计周期相比，本次增加12个临床申报受理号。 国内新药临床申报情况（部分） 。根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）无国内药物获NMPA特殊资格认定。与上个统计周期相比，本次减少4个获监管机构特殊资格认定的药物。 04 国内新药研发进展 根据药渡数据统计分析，本次统计周期（2024.05.25-05.31）国内新药临床研发状态更新共计10条，涉及肿瘤、血液和淋巴疾病共计2个领域。其中，化学药8个，生物药2个。 5月27日，先声再明在ASCO公布Endostar联合同步放化疗与单独同步放化疗治疗局部区域晚期鼻咽癌（LA-NPC）的一项III期实验数据。 结果：2016年11月至2020年7月期间，随机分配了300例LA-NPC患者（CCRT+E组，150例；CCRT组，150例）。截至数据2023年12月，中位随访时间为66个月。意向性治疗分析显示，CCRT+E组患者在放疗后3个月获得更好的CR率（90.0% vs. 80.7%，P=0.022）。CCRT+E组的3年PFS为84.8%，CCRT组为75.1%，3年OS为89.2%vs. 85.3%，3年DMFS为89.7% vs. 80.5%，3年LRRFS为91.5% vs. 90.8%，CCRT+E组和CCRT组患者的3-4级急性和晚期毒性特征相似（61.7% vs. 65.3%）。 结论：在标准CCRT中加入Endostar可显着改善具有良好安全性的LA-NPC患者的3年PFS。 国内新药研发进展情况 05 国内新药研发领域政策法规动态 国家药监局药审中心关于发布《在罕见疾病药物临床研发中应用去中心化临床试验的技术指导原则》的通告（2024年第25号） 为深化“以患者为中心”的临床试验新理念，助力罕见疾病药物临床研发，在国家药品监督管理局的部署下，药审中心组织制定了《在罕见疾病药物临床研发中应用去中心化临床试验的技术指导原则》。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。 06 国内新药研发领域热点新闻 2024ASCO国产ADC药物临床新进展 2024ASCO年会上，国产ADC在各瘤种的临床进展再度收到广泛关注，本期我们来看看国产ADC药物的临床数据更新。 科伦博泰 芦康沙妥珠单抗（SKB264/MK-2870）用于既往接受过治疗的局部复发或转移性三阴性乳腺癌（TNBC）患者的III期研究（OptiTROP-Breast01）结果……更多资讯，请阅读原文 赛诺菲调转船头 近日，赛诺菲「艾沙妥昔单抗注射液」的2.2类上市申请获CDE受理。这是艾沙妥昔单抗在国内递交的第二项上市申请，2023年12月其在国内递交的首个上市申请获CDE受理。 艾沙妥昔单抗（Isatuximab，Sarclisa）是一种IgG1嵌合单克隆抗体，靶向浆细胞CD38受体的特定表位，能够触发多种独特的作用机制，包括促进程序性肿瘤细胞死亡（凋亡）和免疫调节活性。目前，该药已在美国获批两项适应症：联合泊马度胺和地塞米松（pom-dex）治疗至少接受过2种治疗方案(包括来那度胺和一种蛋白酶抑制剂)的复发或难治性多发性骨髓瘤（R/R MM）成人患者（2020.03）；联合卡非佐米和地塞米松（Kd）治疗既往接受过1-3线治疗的R/R MM成人患者（2021.04）。更多资讯，请阅读原文 第一三共ADC，未达到NSCLC试验的OS终点 2024年5月27日，阿斯利康和第一三共报告了其TROP-2 ADC Datopotamab deruxtecan（Dato-DXd），在晚期非鳞状非小细胞肺癌（NSCLC）患者中的III期研究TROPION-Lung01的OS进展。 这项随机、全球、多中心、开放标签的III期临床试验，在既往接受过治疗的局部晚期/转移性NSCLC成人患者（无论可操作的基因组改变状态如何）中，评估Dato-DXd与多西他赛化疗的疗效和安全性。 该项研究设立了双重主要终点，分别为PFS和OS。关键次要终点包括ORR、研究者评估的PFS、DOR、DCR和安全性。更多资讯，请阅读原文 国内第五款三代EGFR抑制剂获批上市 5月20日，根据国家药监局官网公示，上海倍而达药业有限公司申报的1类创新药三代EGFR抑制剂甲磺酸瑞齐替尼胶囊（研发代码BPI-7711，商品名：瑞必达）获批上市，适应症为既往经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的治疗。 从药渡数据库检索可知，瑞齐替尼是国内第五款获批上市的三代EGFR抑制剂，2021年3月9日，石药集团宣布，其全资附属公司石药（上海）有限公司已与上海倍而达药业订立产品授权及商业化协议，通过股权认购获得第三代EGFR-TKI（BPI-7711胶囊）独家产品授权及商业化权利。更多资讯，请阅读原文 III期成功，信达生物计划提交“匹康奇拜单抗”上市申请 2024年5月28日，信达生物宣布其自主研发的IL-23p19抗体注射液匹康奇拜单抗（IBI112），在中国中重度斑块状银屑病受试者中开展的III期临床研究（CLEAR-1）中，达到主要终点和所有关键次要终点。 根据新闻稿，信达生物正在计划向监管机构递交匹康奇拜单抗的银屑病适应症的上市申请。 CLEAR-1研究，是一项多中心、随机、双盲、安慰剂对照的III期临床试验，共纳入了500例患有中重度斑块型银屑病的患者，评估匹康奇拜单抗的有效性和安全性。 受试者按照1:2:2的比例随机接受安慰剂、匹康奇拜单抗200mg（0，4，8周3次给药）后，在20周开始接受200mg或者100mg每12周1次给药的长期维持。更多资讯，请阅读原文 男人的“难言之隐”撑起了多大的市场 随着社会压力内卷、环境恶化及生活节奏过快等变化，男人们的性健康问题开始浮现。然而，一项针对国内男性的调研显示，在出现问题后，会主动采取措施解决的人仅有20.9%。大多数男人在对待这一障碍时，首先采取的是回避的心理。这也可以理解，毕竟涉及到男人最重视的尊严问题，宁可默默承受，也不能公开承认自己不行。 但随着男性的性健康问题日益凸显，相关治疗药物市场规模开始膨胀，正逐渐受到各大药企的关注。 逐渐膨胀的市场 男性的性健康问题主要包括勃起功能性障碍（ED）、早泄、慢性前列腺炎、前列腺增生……更多资讯，请阅读原文 咨询、合作请联系作者 小D有话说 为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“0613创新药周报”，即可下载。

Nearly 98% of patients experience quality of life impact as a result of tardive dyskinesia (TD) including social, psychological, physical and recreational aspects of daily living Data highlight for the first time that TD has a multidimensional impact on patients including those with mild TD severity IMPACT-TD Registry is the largest-ever study of its kind evaluating the holistic effects of TD over three years along with real-world treatment patterns and outcomes with once-daily AUSTEDO® XR (deutetrabenazine) extended-release tablets and twice-daily AUSTEDO® (deutetrabenazine) tablets TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new patient- and physician-reported interim results from the Phase 4 IMPACT-TD Registry study, reinforcing that TD has a wide-reaching, multidimensional impact on patients’ quality of life. These interim findings from the IMPACT-TD study were presented at the 2024 Psych Congress Elevate Annual Meeting, taking place from May 30 – June 2 in Las Vegas, Nevada. “TD can be a devastating setback for those who have achieved mental stability with their psychiatric medication,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “These interim findings from IMPACT-TD Registry, the largest study of its kind, reveal the profound effect that TD can have on a patient’s life, beyond the clinic. Understanding the full impact of TD and how approved treatment options for TD, like once-daily AUSTEDO XR and twice-daily AUSTEDO, can help treat the condition is critical to improving outcomes for patients and is a driving force in our unwavering commitment to developing meaningful solutions for them.” The two-part IMPACT-TD study is a 3-year longitudinal observational study evaluating how TD progresses over time and impacts a patient’s quality of life (Part A), as well as outcomes related to treatment with once-daily AUSTEDO XR and twice-daily AUSTEDO (Part B). Clinician-reported TD severity and impact is assessed using the IMPACT-TD scale, the AIMS (Abnormal Involuntary Movement Scale) and the CGIS-TD (Clinical Global Impression of Severity of TD) scale. The interim analysis includes 286 patients with varying levels of TD severity and highlights, for the first time, that clinicians reported that TD has a multidimensional impact, even on patients with mild TD severity. Clinician-reported IMPACT-TD findings show: 98% of patients experience the impact of TD in some aspect of their quality of life 83% of patients experience moderate to severe impact across various quality of life domains, including social (59%), psychological/psychiatric (70%), physical (53%) and vocational/educational/recreational (57%) 54% and 61% of patients with “very mild” and “mild” TD severity based on CGIS-TD, respectively, experience moderate to severe impact on their quality of life Patient-reported TD impact is assessed using the novel IMPACT-TD PRO (IMPACT-TD Patient-Reported Outcome) scale. Patient-reported findings, as assessed with the IMPACT-TD PRO, show: 59% and 57% of patients reported that TD caused embarrassment in social situations and impacted their ability to enjoy the things they do for fun, respectively 43% of patients reported that TD impacts their sleep 38-42% of patients reported experiencing the physical impact of TD, including on their ability to hold things, do chores and exercise “These data provide a clearer understanding as to how the abnormal movements of TD significantly impact the daily functioning of patients that cannot be gleaned from looking solely at the severity of the movements,” said Richard Jackson, MD, an Assistant Clinical Adjunct Professor in the University of Michigan School of Medicine’s Department of Psychiatry and the study’s lead investigator. “TD can impact all domains of daily functioning including social, psychological, physical, occupational and recreational aspects of daily living even when the abnormal movements appear to be mild. This emphasizes the need for all clinicians to assess not only the severity of a patient’s TD movements but the impact those movements can have on all aspects of life. Continuing to understand the multifaceted impact of TD and finding ways to alleviate these burdens is crucial to supporting patients on their TD journey.” Also presented at Psych Congress Elevate 2024 were data supporting: The development and internal validation of the IMPACT-TD PRO scale, suggesting that the questionnaire can effectively and reliably characterize the multidimensional impact of TD in adult patients. Final results from the TD cohort of the Phase 4 START study, which investigated real-world treatment outcomes for patients starting AUSTEDO with the 4-week Titration Kit. These full START results show that the titration kit successfully helped patients with TD find individualized therapeutic AUSTEDO doses with effectiveness similar to that observed in the pivotal clinical trials, with high adherence and patient satisfaction rates. Findings from a retrospective study comparing healthcare resource utilization (HCRU) in patients with TD treated with benztropine versus non-treated patients with TD suggest that benztropine can result in potential harm and increased cost for the patient if used off-label for the treatment of TD. About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.1,2,3 About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO. INDICATIONS AND USAGE AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. IMPORTANT SAFETY INFORMATION Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression. Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine. Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects. QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems. Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence. Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO. Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects. Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. Please see accompanying full Prescribing Information, including Boxed Warning. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. _________________________ 1 Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs. Hauppauge, NY: Nova Science Publishers. 2013:235-258. 2 Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11. 3 Tardive dyskinesia. National Alliance on Mental Illness website. . Accessed May 4, 2023. View source version on businesswire.com: Contacts PR Contacts Kelley Dougherty +1 (973) 832-2810 Eden Klein +972 (3) 906 2645 IR Contacts Yael Ashman +972 (3) 914 8262 Sanjeev Sharma +1 (973) 658 2700 Ran Meir +1 (267) 468-4475 Source: Teva Pharmaceutical Industries Limited View this news release online at: