ST. GALLEN, Switzerland and SAN DIEGO, April 24, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).

瑞士圣加仑和圣地亚哥，2024年4月24日/PRNewswire/-CSL Vifor and Travere Therapeutics，Inc.（纳斯达克：TVTX）今天宣布，欧盟委员会已授予FILSPARI（sparsentan）有条件上市授权（CMA），用于治疗尿蛋白排泄量≥1.0 g/天（或尿蛋白与肌酐比值≥0.75 g/g）的原发性IgAN成人。

The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway..

CMA适用于欧盟所有成员国，以及冰岛、列支敦士登和挪威。。

'This is a significant step forward for patients in Europe living with IgAN, a rare and serious condition, and a leading cause of end stage renal disease,' said Prof. Dr. med. Jürgen Floege, Senior Professor, Div. Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT clinical trial.

德国亚琛RWTH大学医院肾脏病与临床免疫学系高级教授、PROTECT临床试验指导委员会成员med.Jürgen Floege博士说：“对于欧洲患有IgAN的患者来说，这是向前迈出的重要一步，IgAN是一种罕见而严重的疾病，也是终末期肾病的主要原因。”。

'The approval of this innovative treatment is based on data from the only head-to-head phase-III clinical trial in IgAN. Adult patients with IgAN who are at high risk of progressing to kidney failure will now have access to a new therapy that significantly reduces proteinuria and slows the progression of kidney disease.'.

“这种创新治疗的批准是基于IgAN唯一的头对头III期临床试验的数据。成年IgAN患者进展为肾衰竭的风险很高，现在可以获得一种新的治疗方法，可以显着降低蛋白尿并减缓肾脏疾病的进展。”。

'The approval by the European Commission is an important milestone for the IgAN community in Europe and underscores our promise to develop and deliver innovative medicines in our areas of focus where there is unmet need,' said Emmanuelle Lecomte Brisset, Senior Vice President and Head of Global Regulatory Affairs at CSL.

CSL高级副总裁兼全球监管事务负责人EmmanuelleLecomte Brisset说：“欧盟委员会的批准是欧洲IgAN社区的一个重要里程碑，强调了我们在重点领域开发和提供创新药物的承诺，这些领域的需求尚未得到满足。”。

'We look forward to working with our partners and EU member states to bring this innovative therapy to patients in Europe.'.

“我们期待着与我们的合作伙伴和欧盟成员国合作，将这种创新疗法带给欧洲的患者。”。

'As the first and only non-immunosuppressive therapy approved for IgAN, we believe FILSPARI offers clinicians the potential for a new foundational treatment for this rare kidney disease, replacing RAAS inhibition,' said Eric Dube, Ph.D., President and Chief Executive Officer, Travere Therapeutics. 'With this approval and the commercial strength and expertise of our partner, CSL Vifor, we look forward to people living with IgAN in Europe gaining access to this important medicine.'.

Travere Therapeutics总裁兼首席执行官Eric Dube博士说：“作为第一个也是唯一一个被批准用于IgAN的非免疫抑制疗法，我们相信FILSPARI为临床医生提供了替代RAAS抑制的这种罕见肾脏疾病的新基础治疗的潜力。”有了这一批准以及我们的合作伙伴CSL Vifor的商业实力和专业知识，我们期待着欧洲IgAN患者能够获得这种重要的药物。”。

The European Commission's decision follows the Committee for Medicinal Products for Human Use (CHMP)'s positive opinion in February 2024, based on results from the pivotal phase-III PROTECT study of FILSPARI in IgAN. The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance.

欧盟委员会的决定是根据2024年2月人类使用药品委员会（CHMP）的积极意见做出的，该意见基于IgAN中FILSPARI的关键III期保护研究的结果。PROTECT研究在预先指定的中期分析中达到了其主要终点，具有统计学意义。

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..

治疗36周后，接受FILSPARI治疗的患者的蛋白尿平均从基线水平降低了49.8%，而厄贝沙坦治疗的患者的蛋白尿平均从基线水平降低了15.1%。该研究的两年验证性结果显示，与厄贝沙坦相比，FILSPARI治疗在eGFR慢性斜率终点方面具有统计学意义，并显示出具有临床意义的肾功能保存。。

CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.

CSL Vifor预计将于2024年下半年在第一个欧洲市场推出FILSPARI。

About CSL Vifor

关于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.

CSL Vifor是缺铁和肾脏病药物和创新领先疗法的全球首选合作伙伴。我们专注于战略性全球合作，为精准医疗保健授权和开发、制造和营销药品，旨在帮助世界各地的患者过上更好、更健康的生活。

Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care)..

CSL Vifor总部位于瑞士圣加仑，还包括联合公司Vifor Fresenius Medical Care Renal Pharma（与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, www.cslvifor.com.

母公司CSL（ASX:CSL；USOTC:CSLLY）总部位于澳大利亚墨尔本，拥有32000名员工，为100多个国家的人们提供救生治疗。有关CSL Vifor的更多信息，请访问www.cslvifor.com。

About Travere Therapeutics

关于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.

在Travere Therapeutics，我们的生命是罕见的。我们是一家生物制药公司，每天都会齐聚一堂，帮助各种背景的患者、家属和护理人员应对罕见疾病。在这条道路上，我们知道迫切需要治疗选择，这就是为什么我们的全球团队与罕见病社区合作，以确定、开发和提供改变生命的疗法。

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..

在追求这一使命的过程中，我们不断寻求了解罕见患者的不同观点，并勇敢地开辟新的道路，改变他们的生活，为他们的今天和明天带来希望。有关更多信息，请访问travere.com。。

About IgA Nephropathy (IgAN)

关于IgA肾病（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.

IgAN，也称为伯杰病，是一种罕见的进行性肾脏疾病，其特征是肾脏中免疫球蛋白a（IgA）的积累，这是一种帮助身体抵抗感染的蛋白质。IgA的沉积导致肾脏正常过滤机制的破坏，导致尿液中的血液（血尿），尿液中的蛋白质（蛋白尿）和肾功能的进行性丧失。

Other symptoms of IgAN may include swelling (edema) and high blood pressure..

IgAN的其他症状可能包括肿胀（水肿）和高血压。。

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)

IgAN是全球最常见的原发性肾小球疾病，也是肾衰竭的主要原因。据估计，IgAN将影响许可地区（欧洲、澳大利亚和新西兰）多达250000人

About the PROTECT study

关于PROTECT研究

The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only head-to-head 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, in 404 patients ages 18 years and up with IgAN and persistent proteinuria despite receiving maximum tolerated dose and at least 50% of maximum labelled dose of ACE or ARB therapy.

PROTECT研究是迄今为止IgA肾病（IgAN）中最大的介入研究之一，也是这种罕见肾脏疾病中唯一的头对头试验。这是一项全球性，随机，多中心，双盲，平行组，主动对照临床试验，评估了404名18岁及以上IgAN和持续性蛋白尿患者服用400 mg斯巴森坦（与300 mg厄贝沙坦相比）的安全性和有效性，尽管接受了最大耐受剂量和至少50%的最大标记剂量ACE或ARB治疗。

In August 2021, Travere announced the PROTECT Study met its primary endpoint at the pre-specified interim analysis . Based on the pre-specified, primary analyses set, after 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients (p<0.0001).

2021年8月，Travere宣布PROTECT研究在预先指定的中期分析中达到了其主要终点。根据预先指定的初步分析数据集，治疗36周后，接受斯巴森坦治疗的患者的蛋白尿平均从基线水平降低了49.8%，而厄贝沙坦治疗的患者的蛋白尿平均从基线水平降低了15.1%（p<0.0001）。

The study's confirmatory secondary endpoint in the EU is eGFR chronic slope, measured from week 6 to week 110 of treatment, following the initial acute effect of randomized treatment. The confirmatory secondary endpoint in the U.S. is eGFR total slope from day 1 to week 110 of treatment. In September 2023, Travere announced topline two-year confirmatory secondary endpoint results from the PROTECT Study of sparsentan in IgAN.

该研究在欧盟的证实性次要终点是eGFR慢性斜率，在随机治疗的初始急性效应之后，从治疗的第6周到第110周进行测量。美国的确诊次要终点是治疗第1天至第110周的eGFR总斜率。2023年9月，Travere宣布了IgAN中sparsentan PROTECT研究的topline两年验证性次要终点结果。

Sparsentan demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in eGFR chronic and total slope versus irbesartan achieving statistical significance in eGFR chronic slope for purposes of regulatory review in the EU, and narrowly missing statistical significance in eGFR total slope.

Sparsentan表现出长期的肾功能保存，与厄贝沙坦相比，eGFR慢性和总斜率在临床上有意义的差异，在欧盟监管审查中，eGFR慢性斜率具有统计学意义，而eGFR总斜率的统计学意义却很小。

Patients who completed the PROTECT double-blind portion of the study on treatment were eligible to partic.

完成治疗研究的保护双盲部分的患者有资格参加。

About FILSPARI (sparsentan)

关于FILSPARI（sparsentan）

FILSPARI is a novel, 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). Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, protects podocytes, prevents glomerulosclerosis and mesangial cell proliferation, and reduces proteinuria..

FILSPARI是一种新型的非免疫抑制性单分子双内皮素-血管紧张素受体拮抗剂，对内皮素a受体（ETAR）和血管紧张素II亚型1受体（AT1R）具有高选择性。临床前数据显示，以罕见的慢性肾脏疾病的形式阻断内皮素A型和血管紧张素II 1型途径，保护足细胞，防止肾小球硬化和系膜细胞增殖，并减少蛋白尿。。

For more information please refer to the product overview on the European Medicines Agency website.

有关更多信息，请参阅欧洲药品管理局网站上的产品概述。

FILSPARI was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgAN in Europe and the U.S. FILSPARI is currently available in the U.S. and was granted accelerated approval by the US Food and Drug Administration in February 2023 based on reduction in proteinuria.

FILSPARI由Travere Therapeutics开发，已被授予欧洲和美国治疗IgAN的孤儿药称号。FILSPARI目前在美国上市，并于2023年2月获得美国食品和药物管理局基于蛋白尿减少的加速批准。

CSL Vifor has been granted exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand..

CSL Vifor已被授予FILSPARI在欧洲、澳大利亚和新西兰的独家商业化权利。