- Travere Therapeutics Inc (NASDAQ:TVTX) completed its planned FDA Type A meeting for a potential submission for accelerated approval of sparsentan for focal segmental glomerulosclerosis (FSGS), a rare disease affecting the kidney filters.
- FDA indicated that the interim analysis from the ongoing Phase 3 DUPLEX study and the recent limited additional estimated glomerular filtration (eGFR) data-cut do not meet their threshold to support an application for accelerated approval in FSGS.
- The FDA indicated that the DUPLEX Study maintains the potential for full approval pending completion of the study and recommends that the company pursue traditional approval based on a two-year eGFR slope.
- Travere anticipates having topline data from the DUPLEX Study, including full two-year eGFR data, in 1H of 2023 and filing for full approval in 2H of 2023.
- The company completed a mid-cycle review meeting with the FDA for its marketing application under priority review for accelerated approval of sparsentan for IgA nephropathy.
- The FDA indicated that no advisory committee meeting is expected, and it remains on track for the PDUFA target action date of November 17.
- The company and its partner Vifor Pharma are applying for conditional marketing authorization of sparsentan for IgAN in Europe. Review decision expected in 2H of 2023.
- Price Action: TVTX shares traded 6.25% lower at $22.50 premarket on the last check Thursday.
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