Overview
- Final APPLAUSE-IgAN analysis showed Fabhalta significantly outperformed placebo on the annualized eGFR slope over two years, indicating slower disease progression.
- Researchers reported a favorable and consistent safety profile for the oral Factor B inhibitor, in line with prior data.
- Novartis said it will present the full dataset at upcoming medical meetings and will use the results to support regulatory submissions in 2026.
- Fabhalta already has accelerated approvals to reduce proteinuria in high-risk IgAN in the U.S. and China, plus 2025 approvals for C3 glomerulopathy and prior clearance for PNH.
- Rival programs continue to advance, including an FDA REMS update for Travere’s Filspari and positive Phase 3 Stage A results for telitacicept in China, as Novartis shares ticked higher on the day.