Shots:
The NDA submission was based on the P-III (PROTECT) study to evaluate sparsentan (400mg) vs irbesartan (300mg) in 404 patients aged 18yrs. with IgAN & persistent proteinuria. The US FDA has assigned the PDUFA date on Nov 17, 2022
The trial met its pre-specified interim primary efficacy EPs i.e., patients achieved a mean reduction in proteinuria from baseline of 49.8% vs 15.1% @36wks. of treatment. In the preliminary results, sparsentan was well-tolerated & consistent with its overall observed safety profile
The company is expected the results from the confirmatory EPs analysis in H2’23. Sparsentan is currently being evaluated in the P-III (DUPLEX) study for FSGS
Ref: Globenewswire | Image: Travere Therapeutics
