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6-K: Novartis Receives FDA Accelerated Approval for Fabhalta®

SEC ·  Aug 8, 2024 20:30

Summary by Moomoo AI

Novartis announced FDA accelerated approval for Fabhalta (iptacopan), the first complement inhibitor for reducing proteinuria in adults with primary IgA nephropathy (IgAN). In Phase III APPLAUSE-IgAN interim analysis, Fabhalta achieved a 44% proteinuria reduction from baseline, compared to 9% in placebo, demonstrating a 38% reduction versus placebo (p<0.0001).The approval is based on 9-month proteinuria reduction data, with continued approval contingent on verification of clinical benefit from the ongoing Phase III study measuring eGFR decline over 24 months, expected in 2025. The treatment targets patients with urine protein-to-creatinine ratio ≥1.5 g/g who are at risk of rapid disease progression.Novartis is advancing two additional IgAN therapies: atrasentan, which received FDA filing acceptance in Q2 2024, and zigakibart, currently in Phase III development. IgAN affects approximately 25 people per million worldwide annually, with up to 50% of patients with persistent proteinuria progressing to kidney failure within 10-20 years of diagnosis despite current standard care.
Novartis announced FDA accelerated approval for Fabhalta (iptacopan), the first complement inhibitor for reducing proteinuria in adults with primary IgA nephropathy (IgAN). In Phase III APPLAUSE-IgAN interim analysis, Fabhalta achieved a 44% proteinuria reduction from baseline, compared to 9% in placebo, demonstrating a 38% reduction versus placebo (p<0.0001).The approval is based on 9-month proteinuria reduction data, with continued approval contingent on verification of clinical benefit from the ongoing Phase III study measuring eGFR decline over 24 months, expected in 2025. The treatment targets patients with urine protein-to-creatinine ratio ≥1.5 g/g who are at risk of rapid disease progression.Novartis is advancing two additional IgAN therapies: atrasentan, which received FDA filing acceptance in Q2 2024, and zigakibart, currently in Phase III development. IgAN affects approximately 25 people per million worldwide annually, with up to 50% of patients with persistent proteinuria progressing to kidney failure within 10-20 years of diagnosis despite current standard care.
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