Irbesartan

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN) Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025 EU approval is based on the complete data set from the phase-III PROTECT study ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. Continue Reading "The decision by the European Commission is an important advancement for people living with IgAN in the EU", said Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor. "The standard approval, granted without changes to the indication, underscores the value of our clinical data, the dedication of our teams, and our ongoing commitment to deliver on our promise for patients. We look forward to continuing working closely with healthcare professionals, patient communities, and regulatory bodies to ensure access to FILSPARI across Europe." The European Commission's standard approval of FILSPARI is a meaningful step forward for people living with IgA nephropathy across Europe," said Dr. Jula Inrig, Chief Medical Officer at Travere Therapeutics. "This decision not only validates the strength of the phase-III PROTECT study results but also reinforces our deep commitment to this rare kidney disease community. We remain dedicated to working with our partners, regulators, and healthcare providers to expand access and improve outcomes for those affected by IgAN." The European Commission's decision follows CHMP's recommendation to convert the CMA to standard MA from February 2025. The approval is based on a comprehensive clinical data set, including positive confirmatory results from the pivotal phase-III PROTECT study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA), a non-immunosuppressive therapy for the treatment of IgAN approved in Europe and is currently available in Germany, Austria and Switzerland, following the European Commission's conditional marketing authorization in April 2024 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, cslvifor.com. About Travere Therapeutics At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com. About IgA Nephropathy (IgAN) IgAN, also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure. While rare, IgAN is the most common type of primary glomerular disease worldwide and a leading cause of kidney failure. IgAN is estimated to affect up to 250,000 people in the licensed territories (Europe, Australia and New Zealand). About the PROTECT study The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only head-to-head vs. comparator trial in this rare kidney disease. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of sparsentan, compared to 300 mg of irbesartan (an angiotensin II receptor blocker(ARB)), in 404 patients ages 18 years and up with IgA nephropathy and persistent proteinuria despite receiving at least 50% of maximum label dose and maximally tolerated angiotensin-converting enzyme (ACE) inhibitors or ARB therapy. The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance. After 36 weeks of treatment, patients receiving FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients. The two-year confirmatory results from the study showed treatment with FILSPARI achieved statistical significance on the eGFR chronic slope endpoint versus irbesartan and demonstrated clinically meaningful kidney function preservation. eGFR is a blood test that measure how well kidneys filter waste products from blood. Treatment emergent adverse events were well-balanced between sparsentan and irbesartan, except for dizziness and hypotension. About FILSPARI (sparsentan) FILSPARI is an innovative, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist with high selectivity for the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). FILSPARI was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgA nephropathy in the UK, Europe and the U.S. FILSPARI is currently available in the U.S. and first markets in Europe. CSL Vifor has been granted exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand. For more information, please refer to the Summary of Product Characteristics (SmPC). CSL Vifor Media Contact Thomas Hutter +41 79 957 96 73 [email protected] Travere Therapeutics: Investors 888-969-7879 [email protected] Media 888-969-7879 [email protected] Logo - Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

☝ 点击上方 一键预约 ☝  最新最热的医药健康新闻政策前 言据法伯统计，在整体降压药市场中，以缬沙坦、厄贝沙坦、氯沙坦等为代表的肾素-血管紧张素系统（RAS）药物是在历次国家带量采购（VBP）中被纳入数量最多的降压药类别。此外，根据法伯全渠道数据显示，2023年这类药物在我国总体医疗机构市场规模超过215亿元，且在整体降压药市场中占比最大，达到43.4%，其中又以“沙坦”类单一及联合用药占据较大市场份额。补充说明*本文所述的肾素-血管紧张素系统药物市场范围（按照药物解剖学、治疗学及化学分类法ATC2编码）：C09；*中国医疗机构：包括两个医院渠道（城市医院、县域医院）和两个基层医疗机构渠道（社区卫生中心、乡镇卫生院）。总规模超215亿，“沙坦”类药物占八成市场肾素-血管紧张素系统（renin-angiotensin system，RAS）抑制剂是心肾血管疾病的重要治疗药物，主要包括以卡托普利、依那普利、氨氯地平贝那普利等为代表的血管紧张素转换酶抑制剂（ACEI）单一及联合用药，和以氯沙坦、厄贝沙坦、缬沙坦氢氯噻嗪等为代表的血管紧张素II拮抗剂（ARB）单一及联合用药。图1-2023年各类降压药分渠道销售额占比及C09药物渠道分布数据来源：法伯全渠道数据根据法伯全渠道数据显示，2023年我国总体医疗机构C09类药物销售额达215.7亿元，在整体降压药市场占比43.4%，且在四个医疗机构渠道中均份额最大。此外，该类药物主要在城市医院和社区卫生中心渠道销售（图1）。另外值得关注的是，在C09药物市场中，又以各种“沙坦类”单一及联合用药占据较大的份额，2023年在总体医疗机构销售额分别达63.8亿元和114.8亿元，合计占比近83%（图2）。图2-2023年总体医疗机构各类C09药物销售额及占比数据来源：法伯全渠道数据累计19个分子纳入集采，市场份额超60%2023年在总体医疗机构降压药市场销售额前十的分子，也全部来自上述“沙坦类”药物。其中，排名前五的均为联合用药，沙库巴曲缬沙坦以超40亿元销售额遥遥领先，第二、三名的厄贝沙坦氢氯噻嗪和缬沙坦氨氯地平市场规模均超过15亿元。增速方面，根据法伯全渠道数据显示，除了近年来增长强劲的沙库巴曲缬沙坦，缬沙坦氢氯噻嗪和阿利沙坦也增长较快（图3）。图3-2023年总体医疗机构C09类药物TOP10分子及增速表现数据来源：法伯全渠道数据此外，目前TOP10分子中的8个已经纳入历次国家集采。事实上，C09类药物是降压药市场中被纳入集采最多的类别。根据法伯统计，已经累计有19个品种进入前十批集采，均为口服常释剂型，合计占比达61.8%，涉及到的原研企业包括赛诺菲、诺华、第一三共、勃林格殷格翰等（图4）。图4-C09类药物集采品种及2023年各批次集采销售额占比数据来源：法伯整理；法伯全渠道数据关注集采降价对相关药物市场产生的影响，以2021-2023年开展的第4-8批集采涉及到的6个降压药品种为例，根据法伯全渠道数据显示，除了缬沙坦氨氯噻嗪之外，其余5个品种2023年在总体医疗机构的销售额较2021年均下降，其中盐酸贝那普利降幅最大，达55.5%（图5）。图5-总体医疗机构C09类药物第4-8批集采品种销售额变化23vs21数据来源：法伯全渠道数据外资诺华引领市场，内资华海药业优势明显企业格局方面，整体而言，目前C09类降压药市场由内资企业主导，其2023年在总体医疗机构占比62.7%。分渠道来看，内资企业在除了城市医院之外的三个渠道份额均高于外资，尤其是两类基层医疗机构，占比分别高达74.5%和92.2%（图6）。图6-2023年各渠道C09类药物市场内外资企业销售额占比数据来源：法伯全渠道数据进一步关注2023年C09类药物市场排名前十的企业，根据法伯全渠道数据显示，TOP10企业合计占比近64%，且增速高于整体市场的增长水平。外资企业诺华以24.6%的显著份额优势位居榜首，排名第二的华海药业在内资企业中领先，市场占比8.6%。此外，内资地奥集团近年来在C09领域市场增速较快，2023年同比大涨62.9%（图6）。图6-2023年总体医疗机构C09药物市场销售额TOP10企业及增速数据来源：法伯全渠道数据诺华医院渠道销售为主，创新药带动份额提升作为涉及最多C09类降压药集采品种的外资企业，诺华原研的缬沙坦（商品名：代文）、缬沙坦氨氯地平（商品名：倍博特）、缬沙坦氢氯噻嗪（商品名：复代文）、贝那普利（商品名：洛汀新）相继在第3-5批集采（分别于2020年11月、2021年4月和9月执行）落标。法伯数据显示，集采冲击之下，2022年诺华C09类药物销售额同比降低14.6%，后于2023年恢复增长，整体实现2021-2023复合增长10.8%。此外，两类医院是诺华布局的主要销售渠道（图7）。图7-2021-2023年诺华C09类药物销售额渠道分布数据来源：法伯全渠道数据虽然在集采影响下，诺华多个降压药产品2023年在C09领域的市场份额明显下降，但是与此同时，其原研的血管紧张素受体脑啡肽酶抑制剂（ARNI）类药物沙库巴曲缬沙坦的销售额大幅增长，份额从2021年的8.6%增长到2023年的18.6%（表1），进而带动诺华保持了在C09类细分市场的优势。表1-2021-2023年诺华C09类产品市场份额表现数据来源：法伯全渠道数据华海药业产品丰富，重视广阔市场布局内资企业方面，在C09领域业绩亮眼的企业是华海药业，2023年以8.6%的市场份额排名第二。作为国内心血管类制药龙头企业，华海药业在业界有着“普利专家”、“沙坦之王”的称号，旗下相关产品线丰富，包括厄贝沙坦片、福辛普利那片、厄贝沙坦氢氯噻嗪片、氯沙坦钾片、奥美沙坦酯氢氯噻嗪等，且均已相继纳入集采（表2），是典型的积极参与集采并借此快速实现新产品上量的本土仿制药企。表2-2021-2023年华海药业C09类产品市场份额表现数据来源：法伯全渠道数据此外，公司在销售渠道方面坚持裂变策略，构建了多元化的销售结构，并全面推进市场下沉。根据法伯全渠道数据显示，2021-2023年，包括县域医院、社区卫生中心、乡镇卫生院在内的广阔市场渠道，在华海药业C09类药物销售额的合计贡献超过60%，尤其是社区卫生中心，到2023年占比已接近城市医院（33.3% V.S. 33.4%）（图8）。图8-2021-2023年华海药业C09类药物销售额渠道分布数据来源：法伯全渠道数据事实上，从2023年C09市场TOP10企业的销售额渠道分布也能明显看出，外资企业更加重视对城市医院的布局，但大部分内资企业则是重点布局广阔市场渠道，除了华海药业之外，福元医药、华润双鹤和扬子江药业在两个基层医疗机构渠道的份额均超过40%（图9）。图9-2023年总体医疗机构C09类药物市场TOP10企业渠道分布数据来源：法伯全渠道数据地奥集团增速最快，2023年大涨62.9%在C09类降压药领域，另一个值得关注的内资企业是地奥集团，其2021-2023年在我国总体医疗机构的销售额复合增长25.6%（图10），2023年同比大涨62.9%，排名上升十位后进入TOP10企业榜单。良好的市场表现主要得益于旗下氨氯地平贝那普利片（Ⅱ）的增长，根据法伯全渠道数据显示，该产品在我国总体医疗机构的销售额从2021年的近3.6亿增长到2023年的逾6.6亿，复合增长36.3%。图10-2021-2023年地奥集团C09类药物市场规模数据来源：法伯全渠道数据(来源：法伯科技  ）药闻康策新媒体矩阵微信公众号点击下方  一键关注  【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看