Business
Travere Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Sparsentan for the Treatment of IgA Nephropathy
PDUFA target action date of November 17, 2022 SAN DIEGO, May 16, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced the U.S.
About this update from Travere Therapeutics, Inc.
[{"type":"text","content":"PDUFA target action date of November 17, 2022\nSAN DIEGO, May 16, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of its New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN). The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss the application and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 17, 2022. “For decades people living with IgA nephropathy have had limited treatment options while facing a progression toward end-stage kidney disease. If approved, sparsentan would be the first FDA-approved non-immunosuppressive treatment option for IgA nephropathy, and we aspire to ultimately position sparsentan as a new standard of care,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Acceptance of the NDA and being granted Priority Review brings us one step closer to potentially delivering sparsentan to the IgA nephropathy community before the end of this year, and we look forward to continuing to work with the FDA throughout the review process.” The NDA submission for sparsentan is supported by results from the ongoing pivotal Phase 3 PROTECT Study, one of the largest interventional studies to date in IgAN. The PROTECT Study evaluating sparsentan in 404 patients with persistent proteinuria, met its pre-specified interim primary efficacy endpoint measuring change in proteinuria compared to the active control irbesartan. After 36 weeks of treatment, patients receiving sparsentan achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients (p","length":2296,"tagName":"div"}]