Travere readout in IgA nephropathy sets up accelerated path to rival Calliditas’ therapy

An interim Phase III readout positions Travere to submit an NDA seeking sparsentan’s accelerated approval in IgA nephropathy, setting it up to compete with a therapy from Calliditas that’s already under FDA priority review.

Travere Therapeutics Inc. (NASDAQ:TVTX) said Monday that dual angiotensin and endothelin receptor antagonist sparsentan led to a mean reduction in proteinuria from baseline of 49.8% at 36 weeks vs. 15.1% for an active control group treated with angiotensin II receptor blocker irbesartan (p<0.0001), meeting the interim primary efficacy endpoint in the 404-patient, Phase III PROTECT trial...