Travere Therapeutics Inc TVTX announced topline two-year confirmatory secondary endpoint results from its head-to-head Phase 3 PROTECT Study of Filspari (sparsentan) in IgA nephropathy (IgAN) versus Sanofi SA's SNY Avapro (irbesartan).
Filspari demonstrated long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate (eGFR) total and chronic slope versus irbesartan, narrowly missing statistical significance in eGFR total slope while achieving statistical significance in eGFR chronic slope for purposes of regulatory review in the EU.
Also Read: Travere Therapeutics Offloads Bile Acid Product Portfolio: Says Divestment Strengthens Financial Foundation.
Filspari is currently available under accelerated approval in the U.S. The company will engage with regulators and expects to submit a supplemental New Drug Application in 1H 2024 for full approval in the U.S.
In the 404-patient study, a preliminary review of the safety results through 110 weeks of treatment indicates that Filspari was generally well-tolerated.
In August 2022, the European Medicines Agency accepted for review the Conditional Marketing Authorization application of sparsentan for IgAN.
Together with its partner CSL Vifor, the company anticipates a review opinion by the Committee for Medicinal Products for Human Use on the CMA application for sparsentan for IgAN in the EU around year-end.
Price Action: TVTX shares are down 44.90% at $7.11 on the last check Thursday.
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