The FDA approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in adults with complement 3 glomerulopathy (C3G), the agency announced Thursday. "C3G is a debilitating disease ...

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).

Current treatment methods for C3 glomerulopathy (C3G) help support kidney function and suppress immune system activity. Emerging therapies interrupt the proteins responsible for disease activity.

The March 20 approval of Fabhalta covers the treatment of adults with C3 glomerulopathy (C3G), a disease affecting glomeruli, tiny blood vessels in the kidney responsible for filtering waste from ...

With a new FDA approval, the company’s Fabhalta has become the first treatment endorsed by the agency for the ultrarare kidney disease complement 3 glomerulopathy (C3G). But analysts spotted ...

“Efficacy is critically important when treating C3G and IC-MPGN given the high risk of progression to kidney failure.” A Prescription Drug User Fee Act target date of July 28, 2025 has been ...

“Efficacy is critically important when treating C3G and IC-MPGN given the high risk of progression to kidney failure. As a disease-modifying therapy, EMPAVELI has the potential to make a life ...

Designed in partnership with C3G clinicians and patients ... We are looking forward to extending our partnership with the rare kidney disease community with this second program in a rare kidney ...

Iptacopan is the only oral inhibitor of the alternative complement pathway to selectively target the underlying cause of the C3G, a disease that causes inflammation and damage to the kidney ...