regulatory
confidence high
sentiment positive
materiality 0.80
Travere plans sNDA for FILSPARI in FSGS after FDA Type C meeting
Travere Therapeutics, Inc.
- Completed Type C meeting with FDA; sNDA seeking traditional approval for FILSPARI in FSGS expected by end of Q1 2025.
- sNDA will rely on existing Phase 3 DUPLEX and Phase 2 DUET study data for FILSPARI.
- PARASOL workgroup findings show proteinuria reduction over 24 months strongly linked to lower kidney failure risk in FSGS.
- If approved, FILSPARI could become first and only approved therapy indicated for FSGS, a rare kidney disorder.