FDA accepts sparsentan for priority review as treatment of IgA nephropathy

Shares of Travere Therapeutics (Nasdaq: TVTX) were up 13% at $25.08 in early trading today, as it revealed that the US Food and Drug Administration 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, president and chief executive 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,” he noted.