Novartis Reports Pre-Specified Interim Analysis Results from the P-III Study (APPLAUSE-IgAN) for Iptacopan to Treat IgA Nephropathy
Shots:
- The P-III study evaluating iptacopan (200mg) vs PBO in 470 adult primary IgAN patients which met its pre-specified interim analysis 1EPs & demonstrated the superiority of iptacopan vs PBO in proteinuria reduction
- Additionally, highly significant proteinuria reduction on top of supportive care in patients with IgAN & the safety profile was consistent with prior reported data
- Iptacopan is currently being studied in P-III study (APPEAR-C3G) for C3 glomerulopathy, (APPELHUS) for atypical hemolytic uremic syndrome & (APPARENT) for immune complex membranoproliferative glomerulonephritis. The company plans to review interim results with the US FDA to enable regulatory submission for accelerated approval in 2024
Ref: Novartis | Image: Novartis
Related News:- Novartis Presents P-III Trial (APPOINT-PNH) Results of Iptacopan for the Treatment of Paroxysmal Nocturnal Hemoglobinuria at EBMT 2023
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