RegulatoryApr 14, 2026, 06:07 AM
Travere Therapeutics' FILSPARI Gets FDA Approval for FSGS
AI Summary
Travere Therapeutics announced FDA approval for FILSPARI (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. This marks FILSPARI as the first and only FDA-approved medicine for FSGS, expanding its use beyond IgA nephropathy into a second rare kidney disease. The company estimates an addressable U.S. population of over 30,000 individuals for this indication, with the Phase 3 DUPLEX study demonstrating significant proteinuria reduction compared to irbesartan.
Key Highlights
- FDA approved FILSPARI for FSGS in patients aged 8 years and older without nephrotic syndrome.
- FILSPARI is the first and only FDA-approved medicine for FSGS, expanding beyond IgA nephropathy.
- Estimated addressable U.S. population for this indication is over 30,000 individuals.
- Phase 3 DUPLEX study showed 46% proteinuria reduction with FILSPARI vs 30% with irbesartan.
- In non-nephrotic FSGS patients, FILSPARI achieved 48% proteinuria reduction vs 27% with irbesartan.