NDA filed for sparsentan for the treatment of IgA nephropathy.
Travere Therapeutics, Inc. has announced that it has submitted a New Drug Application (NDA) to the FDA under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN).
“There is a clear need for novel treatment options that can reduce proteinuria and slow the devastating progression towards end-stage kidney disease for people living with IgA nephropathy,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “The submission of this NDA marks an important milestone on our path to potentially making sparsentan, if approved, a new treatment standard for the rare kidney disease community, and we look forward to working with the FDA during the upcoming review process.”
The NDA submission is supported by positive interim results from the ongoing pivotal Phase III PROTECT Study, a global, randomized, active-controlled study evaluating the safety and efficacy of sparsentan in a total of 404 patients with IgAN, as well as data from additional clinical trials and pre-clinical testing of sparsentan. The Company expects to receive notice regarding the acceptance of the NDA, as well as the timeline for NDA review, from the FDA in May 2022.
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