Iptacopan

Novartis presents 12-month APPEAR-C3G data showing Fabhalta sustained proteinuria reduction, improved eGFR slope, and favorable safety profile in C3G patients, positioning it as the only oral alternative complement pathway inhibitor for this ultra-rare kidney disease.

Novartis presented 12-month Phase III APPEAR-C3G study data at ASN Kidney Week 2024, showing oral Fabhalta (iptacopan) with supportive care in C3G patients led to significant, sustained proteinuria reduction and improved eGFR slope, with a favorable safety profile.

Novartis presents 12-month APPEAR-C3G data showing Fabhalta sustained proteinuria reduction in C3G patients, improved eGFR slope, and favorable safety profile. Fabhalta is the only oral alternative complement pathway inhibitor for C3G, with regulatory submissions completed in EU, China, and Japan, and expected in the US by year-end.

Novartis' oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial, showing sustained proteinuria reduction and improved eGFR slope, with a favorable safety profile. Fabhalta is the only oral alternative complement pathway inhibitor targeting C3G's underlying cause, with regulatory submissions completed in the EU, China, and Japan, and expected in the US by year-end.

Otsuka's anti-APRIL antibody sibeprenlimab showed significant reduction in uPCR in a phase 3 trial for IgA nephropathy, prompting potential FDA submission. Final results expected in 2026. Competitors include Novartis' zigakibart, Vertex's povetacicept, and Vera's atacicept.