Travere Therapeutics, Inc. 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).

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<0.0001). Preliminary results at the time of the interim assessment suggested that sparsentan had been generally well-tolerated in the study and consistent with its overall observed safety profile.

According to the FDA, a Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Read more here.