MPR1d
Fabhalta Approved as First Treatment for C3 Glomerulopathy
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.
Novartis12d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
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) ...
pharmaphorum11d
Fabhalta is first FDA-approved therapy for rare disease C3G
Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting ...
PharmExec8d
FDA Approves Novartis’ Fabhalta for C3 Glomerulopathy
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 ...
Fierce Pharma11d
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...
MedCity News9d
Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels
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 ...
FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
Novartis' Fabhalta receives FDA approval for C3 glomerulopathy, expanding its kidney disease portfolio as global regulatory ...
FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals
Apellis' Empaveli receives FDA Priority Review for rare kidney diseases C3G and IC-MPGN. Phase 3 data show strong efficacy in proteinuria reduction.
Morgan Stanley says Fabhalta’s label leaves opportunity for Apellis’ Empaveli
Morgan Stanley analyst Judah Frommer notes that Novartis (NVS) has received FDA approval for Fabhalta for C3G. The label comes with a few ...
WGHP12d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)
"This approval of Fabhalta is historic for the entire C3G community as now, for the first time, we have a therapy that is believed to treat the underlying cause of the disease, providing the ...