2024 planned regulatory submission for Novartis' Phase III Fabhalta (iptacopan) for ultra-rare kidney disease C3G, showing 35.1% reduction in proteinuria.
Novartis' Phase III Fabhalta (iptacopan) study for C3 glomerulopathy (C3G), an ultra-rare kidney disease with no approved treatments, showed a 35.1% reduction in proteinuria (a kidney damage marker) compared to placebo. The drug, an oral Factor B inhibitor, has a favorable safety profile and targets the alternative complement pathway. Regulatory submissions for the adult C3G indication are planned for the second half of 2024.
May 25, 2024
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