MPR9h
Pegcetacoplan Gets Priority Review for Two Rare Kidney Diseases
The supplemental New Drug Application for the C3G and IC-MPGN indications is supported by data from the phase 3 VALIANT study.
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.
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.
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 ...
MedPage Today on MSN11d
First Drug Approved for Ultra-Rare Kidney Disease
The FDA approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in adults with complement 3 glomerulopathy ...
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 ...
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 ...
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) ...
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 ...
The American Journal of Managed Care11d
FDA Approves Oral Iptacopan for C3 Glomerulopathy
The FDA approved oral iptacopan (Fabhalta; Novartis) to reduce proteinuria in adults with C3 glomerulopathy (C3G), according ...
Medical Dialogues10d
FDA Approves First oral Treatment for rare Glomerulopathy
The US Food and Drug Administration (FDA) has approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in ...
Zacks Investment Research on MSN11d
FDA Approves Novartis Drug for Rare Kidney Disease Treatment
Novartis NVS announced that the FDA has approved Fabhalta (iptacopan) for a third indication. The regulatory body approved ...