FDA Accepts Travere Therapeutics' NDA for Sparsentan with Priority Review

The U.S. Food and Drug Administration (FDA) has accepted Travere Therapeutics’ TVTX New Drug Application (NDA) under Subpart H and granted Priority Review of sparsentan for the treatment of IgA nephropathy (IgAN).

The regulatory agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 17, 2022.

The New Drug Application (NDA) is supported by results from the ongoing pivotal Phase 3 PROTECT Study, for the treatment of IgA nephropathy (IgAN).

Eric Dube, Ph.D., president and chief executive officer, commented : ”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”.

The Priority Review designation directs overall attention and resources to the evaluation of applications for drugs, while the review window gets shortened to six months.

Travere Therapeutics trading high 9 percent at $24.11