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

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.