With sNDA, Travere Hopes to Expand Use of Sparsentan to FSGS

Travere Therapeutics announced that it has completed a Type C meeting with the FDA and plans to submit a supplemental New Drug Application (sNDA) requesting traditional approval of sparsentan (Filspari) for focal segmental glomerulosclerosis (FSGS) by the end of the first quarter of 2025.

If the sNDA is approved, sparsentan could become the first and only FDA-approved medicine for the treatment of FSGS, a rare kidney disorder and leading cause of kidney failure. FSGS is estimated to affect more than 40,000 patients in the United States.

The sNDA will be based on data from the phase III DUPLEX and phase II DUET studies. DUPLEX, the largest interventional study to date in FSGS and the only study in FSGS against a maximally dosed active comparator, showed that sparsentan delivered clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and a lower rate of end-stage renal disease compared with the active control. DUET demonstrated a greater than twofold reduction in proteinuria with sparsentan compared with irbesartan.

The results of the two studies align with recent findings from the international collaborative PARASOL (Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis) workgroup, which determined that in FSGS, reduction in proteinuria over 24 months is strongly associated with a reduction in the risk of kidney failure.

Currently, sparsentan is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Source: Press release