Novartis Reports Positive 12-Month Outcomes for Fabhalta in C3 Glomerulopathy Treatment

Novartis has shared encouraging 12-month results from the Phase III APPEAR-C3G study, presented at the ASN Kidney Week 2024, focusing on the treatment of C3 glomerulopathy (C3G) with Fabhalta (iptacopan). The study demonstrated that patients receiving oral Fabhalta in combination with supportive care experienced significant and sustained reductions in proteinuria over a year. These benefits were evident as early as 14 days into the treatment and persisted throughout the 12-month period. Additionally, during the study's open-label phase, participants switching to Fabhalta also exhibited reduced proteinuria levels.

The study further highlighted improvements in the estimated glomerular filtration rate (eGFR) slope with the initiation of Fabhalta, contrasting with the patients' previous rapid decline. Importantly, Fabhalta maintained a favorable safety profile, with no new safety concerns emerging during the trial.