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).

A phase 2 trial of iptacopan in patients with the rare kidney disease C3 glomerulopathy (C3G) – which causes progressive kidney failure and has no approved treatments – showed reductions in ...

Findings from the APPEAR-C3G trial showed a 35% reduction in 24-hour UPCR from baseline (primary endpoint) in the iptacopan group compared with the placebo group. The Food and Drug Administration ...

Carla Nester, MD, MSA, FASN, is coinvestigator for the ongoing APPEAR-C3G trial (NCT04817618), data from which were used to support the FDA’s recent approval of iptacopan (Fabhalta; Novartis ...

“C3G is a debilitating disease often affecting young people, impacting many aspects of their physical and emotional health, and our previous treatment options came with significant challenges ...

The FDA has approved Novartis’ Fabhalta (iptacopan) as the first and only treatment for C3 glomerulopathy (C3G). Previously, patients with C3G were forced to rely on supportive care and broad ...

Highlights from CHMP’s February 24–27 meeting described C3G as “ultra-rare” and clarified that Fabhalta has already been granted orphan drug designation (1,2). Novartis announced CHMP’s decision in a ...

Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for the ultra-rare kidney disease complement 3 glomerulopathy (C3G). Every ...

This marks the first authorized treatment specifically for C3G, aimed at reducing proteinuria, a condition of excess protein in urine which is a common symptom of kidney diseases. Prior to this ...

Basel, March 20, 2025 - Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G) ...