The approval of iptacopan in reducing proteinuria in adult patients with native kidney C3G was based on data from the randomized, double-blind, placebo-controlled, phase 3 APPEAR-C3G trial.
Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting ...
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 ...
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) ...
The FDA approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in adults with complement 3 glomerulopathy ...
The FDA approved oral iptacopan (Fabhalta; Novartis) to reduce proteinuria in adults with C3 glomerulopathy (C3G), according ...
Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...
The FDA on Thursday approved Fabhalta (iptacopan) to treat complement 3 glomerulopathy (CG3), a progressive, ultrarare kidney ...
On Thursday, the U.S. Food and Drug Administration (FDA) approved Novartis AG’s (NYSE:NVS) oral Fabhalta (iptacopan) for ...
This is the third indication for Fabhalta after Novartis won FDA approval of the small molecule in paroxysmal nocturnal ...
[MUSIC PLAYING] FRITA MCRAE FISHER: C3 glomerulopathy, also known as C3G, is a kidney disease where there are certain deposits in the glomeruli. The glomeruli are the kidney's filtering units.
Novartis NVS announced that the FDA has approved Fabhalta (iptacopan) for a third indication. The regulatory body approved ...