Novartis Announces FDA Accelerated Approval of Firdapse® (Iptacopan), the First and Only Complement Alternative Pathway Inhibitor for Reducing Proteinuria in Adults with Primary IgA Nephropathy at Risk of Rapid Progression

RecentlyNovartisAnnounce,The US Food and Drug Administration (FDA) has granted accelerated approval to the first-in-class complement inhibitor Fihda.^®(Iptacopan Hydrochloride Capsules), used to reduce proteinuria (generally referring to a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g) in adult patients with primary IgA nephropathy (IgAN) who are at risk of rapid progression.Iptacopan capsules effectively target the alternative complement pathway of the immune system, and the excessive activation of the complement system in the kidneys is considered one of the pathogenic mechanisms of IgAN. This is also the first approval of a product in Novartis' renal disease pipeline. Other products in this pipeline include Atrasentan and Zigakibart.

The accelerated approval of this indication is based on the pre-specified interim analysis of the APPLAUSE-IgAN Phase III clinical study. The study showed that, compared with the placebo group, patients experienced a significant reduction in proteinuria after 9 months of treatment. The study will continue to evaluate the delay of progression in kidney function with ipokapron hydrochloride capsules by measuring the decline in estimated glomerular filtration rate (eGFR) over 24 months. The eGFR data are expected to be completed and announced in 2025, which will support the FDA's full approval.