Travere Therapeutics Reports US FDA Acceptance of NDA and Priority Review for Sparsentan to Treat IgA Nephropathy
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
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
