Ad hoc announcement pursuant to Art. 53 LR
- Phase III APPEAR-C3G study met its primary endpoint, demonstrating superiority of iptacopan vs. placebo in proteinuria reduction at six-month analysis1; the safety profile of iptacopan was consistent with previously reported data1-3
- C3 glomerulopathy (C3G) is an ultra-rare complement-mediated kidney disease, with approximately 50% of patients progressing to kidney failure within 10 years of diagnosis4-7; currently no treatments address the underlying cause of C3G7-9
- Novartis plans to review results with global health authorities to enable potential submissions in 2024; data will be submitted for presentation at an upcoming medical meeting
- Iptacopan demonstrated positive Phase III results in IgA nephropathy (IgAN) at the interim analysis and a late-stage development program is ongoing across four investigational indications10-14