- The European Medicines Agency (EMA) has accepted Travere Therapeutics Inc TVTX and CSL Vifor's 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.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.