Novartis Reports the US FDA’s Approval of Fabhalta (Iptacopan) to Treat C3 glomerulopathy
Shots:
- The US FDA has approved Fabhalta (factor B inhibitor) for the treatment of C3 glomerulopathy (C3G) following CHMP positive opinion in Feb 2025; MAA under review in China & Japan
- Approval was based on P-III (APPEAR-C3G) trial assessing safety & efficacy of Fabhalta (200mg, BID, PO) vs PBO in C3G adults for 6mos. followed by an additional 6mos. of Fabhalta administration in all pts incl. subjects on PBO; enrollment ongoing for C3G adolescent cohort
- Study showed reduction in proteinuria as early as 14 days (1EP), sustained at 12mos., with decrease also observed in pts who switched to Fabhalta
Ref: Novartis | Image: Novartis
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
