regulatory
confidence high
sentiment positive
materiality 0.85
FDA approves Travere's FILSPARI for FSGS without nephrotic syndrome, expanding label beyond IgAN
Travere Therapeutics, Inc.
- FDA approved FILSPARI (sparsentan) for FSGS without nephrotic syndrome in patients aged 8+, second indication.
- Addressable U.S. population estimated >30,000 individuals with FSGS without nephrotic syndrome.
- Phase 3 DUPLEX: 48% proteinuria reduction in non-nephrotic patients vs 27% irbesartan (p=0.0075).
- eGFR benefit: treatment difference 1.1 mL/min/1.73m2 at Week 108 favoring FILSPARI.
- Safety profile comparable to irbesartan, consistent with prior programs.