MPR2d
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.
MedCity News4d
Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels
Overactivation of this pathway leads to deposits of the complement protein C3 in glomeruli, triggering inflammation and kidney damage. Fabhalta is an oral small molecule designed to bind to and ...
FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
On Thursday, the U.S. Food and Drug Administration (FDA) approved Novartis AG’s (NYSE:NVS) oral Fabhalta (iptacopan) for ...
Fierce Pharma6d
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 ...
Novartis6d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...
pharmaphorum6d
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 ...
PMLive2d
Novartis’ Fabhalta granted FDA approval to treat ultra-rare kidney disease C3G
Novartis’ oral Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) as the first treatment for ...
The American Journal of Managed Care6d
FDA Approves Oral Iptacopan for C3 Glomerulopathy
The FDA approved oral iptacopan (Fabhalta; Novartis) to reduce proteinuria in adults with C3 glomerulopathy (C3G), according ...
C&EN2d
Macular degeneration focused firm eyes the clinic after series B
The protein complement Factor H and the related FHL-1 ... Two approved complement inhibitors — Apellis’s C3 inhibitor pegcetacoplan (Syfovre) and Astellas’s C5 inhibitor avacincaptad pegol ...
Pharmabiz5d
US FDA approves Novartis’ oral Fabhalta for treatment of adults with C3 glomerulopathy
US FDA approves Novartis’ oral Fabhalta for treatment of adults with C3 glomerulopathy: Basel Saturday, March 22, 2025, 09:00 Hrs [IST] Novartis announced that oral Fabhalta (ip ...