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Travere, CSL's Sparsentan Application Is Under European Review For Rare Kidney Disorder

Travere, CSL's Sparsentan Application Is Under European Review For Rare Kidney Disorder

Travere，CSL的Sparsenan申请正在接受欧洲对罕见肾脏疾病的审查
Benzinga Real-time News ·  2022/08/22 10:00
  • The European Medicines Agency (EMA) has accepted Travere Therapeutics Inc (NASDAQ:TVTX) and CSL Vifor's (OTC:CSLLY) conditional marketing application for sparsentan for IgA nephropathy (IgAN), a rare kidney disorder and a leading cause of end-stage kidney disease (ESKD). 
  • A review decision on a potential approval is expected in the second half of 2023.
  • The EMA filing is supported by positive topline interim results from the ongoing Phase 3 PROTECT Study.
  • Related Content: FDA Says Travere's Sparsentan Data Not Sufficient For Accelerated Approval In One Indication.
  • The PROTECT study met its pre-specified interim primary efficacy endpoint with statistical significance. 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. 
  • Sparsentan is also being evaluated in the pivotal Phase 3 DUPLEX Study for focal segmental glomerulosclerosis (FSGS), another rare progressive kidney disorder.
  • Price Action: TVTX shares traded 0.08% higher at $26.54 on the last check Monday.
  • 欧洲药品管理局(EMA)已接受Travere治疗公司(纳斯达克：东方卫视)和中超Vifor的(场外交易代码：CSLLY)斯帕森坦治疗IgA肾病(IgAN)的条件营销应用程序，这是一种罕见的肾脏疾病，也是终末期肾病(ESKD)的主要原因。
  • 关于潜在批准的审查决定预计将在2023年下半年做出。
  • EMA申请得到了正在进行的第三阶段保护研究的积极的TOPLINE中期结果的支持。
  • 相关内容： FDA称Travere的Sparsenan数据不足以在一个适应症中加速批准.
  • PROTECT研究达到了其预先指定的临时主要疗效终点，具有统计学意义。在36周的治疗后，接受斯帕森坦治疗的患者的蛋白尿平均比基线减少了49.8%，相比之下，接受厄贝沙坦治疗的患者的蛋白尿平均比基线减少了15.1%。
  • 司帕森坦也正在接受另一种罕见的进行性肾脏疾病局灶性节段性肾小球硬化(FSGS)的关键3期双重研究的评估。
  • 价格行动：TVTX股价周一尾盘上涨0.08%，至26.54美元。
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