FILSPARI received conditional marketing authorization (CMA) from European Commission for treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (Urine Protein: Creatinine > 0.75g/g)
The approval is based on PROTECT (P-III) study, evaluating safety and efficacy of sparsentan (400 mg) vs irbesartan (300 mg). Study met 1EPs: statistical significance at pre specified interim analysis; mean reduction in proteinuria with Sparsentan (49.8%) and Irbesartan (15.1%) after 36wks
First EU market launch of FILSPARI, a non-immunosuppressive therapy is expected in H2’24
Ref: CSL Vifor | Image: CSL Vifor
Related News:- CSL Vifor and Travere Therapeutics’ Filspari (sparsentan) Gains CHMP’s Positive Opinion to Treat IgA Nephropathy
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