Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN
RegulatoryapprovedFabhaltaPositive
AI Analysis
Summary
Novartis received FDA traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary IgAN, becoming the first and only complement inhibitor approved for this indication. The approval was based on Phase 3 APPLAUSE-IgAN study data showing statistically significant improvement in eGFR decline compared to placebo.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
FDA traditional approval for Fabhalta to slow kidney function decline in adults with primary IgAN. First and only complement inhibitor with this indication. Priority review designation. Previous accelerated approval in August 2024.
Importance:9/10
Sentiment:
0.95
FDA approvalcomplement inhibitorkidney diseaseIgANPhase 3APPLAUSE-IgANpriority reviewfirst-in-class
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Published by GlobeNewswire Pharma on July 16, 2026 11:02 PM