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Travere获得FDA全面批准肾脏药物Filspari
2024-09-06 18:45
- Travere Therapeutics (NASDAQ:TVTX) traded higher in the premarket on Friday after the U.S. Food and Drug Administration (FDA) granted full approval for its kidney disease drug, Filspari (sparsentan).
- The once-daily oral medication developed by Travere (TVTX) in partnership with Ligand Pharmaceuticals (NASDAQ:LGND) was granted the FDA’s accelerated approval in Feb. 2023 to reduce proteinuria in adults with IgA nephropathy, a rare progressive kidney disease.
- While accelerated approval was based on the surrogate marker of proteinuria, long-term confirmatory results from the company’s PROTECT study backed its full approval.
- “Full approval now enables physicians to confidently prescribe FILSPARI more broadly as a once-daily, oral, non-immunosuppressive treatment, that can provide superior preservation of kidney function and replace current standard of care,” said Travere (TVTX) CEO Eric Dube.
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