21 March 2022 - Travere Therapeutics today announced that it has submitted a new drug application to the U.S. FDA under Subpart H for the accelerated approval of sparsentan for the treatment of IgA nephropathy.

The submission is supported by positive interim results from the on-going pivotal Phase 3 PROTECT trial, a global, randomised, active controlled study evaluating the safety and efficacy of sparsentan in a total of 404 patients with IgA nephropathy, as well as data from additional clinical trials and pre-clinical testing of sparsentan.

Read Travere Therapeutics press release