C3 glomerulopathy first approved treatment with oral complement inhibitor therapy and rare kidney disease research
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Novartis Receives FDA Approval for Fabhalta in C3 Glomerulopathy

Novartis announces FDA approval of Fabhalta (iptacopan) for adults with C3 glomerulopathy, the first approved therapy for this rare kidney disease.

Novartis today announced that the FDA has approved Fabhalta (iptacopan) for the treatment of adults with C3 glomerulopathy (C3G). This approval makes Fabhalta the first therapy approved specifically for C3G, a rare, progressive kidney disease with no previously approved treatments. The approval was based on results from the Phase 3 APPEAR-C3G trial, which demonstrated a statistically significant 35.1% reduction in proteinuria compared to placebo at 6 months. Fabhalta is an oral proximal complement inhibitor targeting Factor B of the alternative complement pathway. This approval represents a major advancement for patients with C3G.

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