CSL Vifor and Travere Reports the EMA’s Acceptance of Conditional Marketing Authorization Application for Review of Sparsentan to Treat IgA Nephropathy
Shots:
- The EMA has accepted the CMA application for sparsentan’s review to treat IgAN. The EMA’s decision is expected on H2’23
- The EMA submission was based on an ongoing P-III (PROTECT) study to evaluate sparsentan vs irbesartan in 404 patients aged 18yrs. with IgAN along with additional clinical studies. The (PROTECT) study met its pre-specified interim primary efficacy EPs i.e., patients achieved a mean reduction in proteinuria from baseline (49.8% vs 15.1%) @36wks. & the therapy was well-tolerated & consistent with its overall observed safety profile, based on the preliminary results
- The results from the confirmatory EPs analysis are expected in H2’23. If sparsentan is approved, it will be the first treatment for patients with IgAN in the EU
Ref: CSL Vifor | Image: CSL Vifor
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