Novartis Secures FDA Approval for First C3 Glomerulopathy Treatment

Novartis has received FDA approval for Fabhalta (iptacopan), the first and only treatment for adults with C3 glomerulopathy (C3G), aimed at reducing proteinuria. This approval marks a significant advancement for patients suffering from C3G, a progressive and ultra-rare kidney disease that previously had no approved therapies and often results in kidney failure. The oral medication targets the underlying cause of the disease by inhibiting the alternative complement pathway, offering new hope to those who have relied on supportive care and symptom management. Carla Nester, a nephrology expert, highlighted the historic nature of this approval for the C3G community, while patient advocate Lindsey Fuller expressed relief and hope for improved quality of life. The approval follows a successful phase 3 trial demonstrating sustained proteinuria reduction and a favorable safety profile. Additionally, regulatory reviews for Fabhalta are ongoing in Europe, China, and Japan, indicating potential for broader access to this new treatment.