Browsing Tag
iptacopan
5 posts
Novartis Fabhalta wins first FDA traditional approval to slow IgAN kidney decline
Novartis has won FDA traditional approval for Fabhalta to slow kidney function decline in adults with primary IgA nephropathy, upgrading a 2024 accelerated label into the first full complement-inhibitor claim on eGFR. The decision moves Novartis ahead of Vera Therapeutics' Trutakna, which received only accelerated approval on 7 July, and lands one day before the Novartis Q2 2026 earnings release. The commercial question is whether Fabhalta's oral, disease-modifying label can convert into a durable IgAN franchise against a widening field of complement, endothelin and B-cell targeted therapies.
Will multi-year kidney function data secure Vanrafia’s long-term positioning?
Novartis Pharma AG’s ALIGN data test whether eGFR slope preservation can confirm Vanrafia’s clinical benefit. Read the full executive analysis.
Will Novartis’ oral drug iptacopan change the game in myasthenia gravis treatment?
Novartis gains FDA orphan designation for iptacopan in myasthenia gravis. Explore how this oral drug could shift neurology and rare disease strategy.
Novartis wins FDA approval for Fabhalta, the first treatment for C3 glomerulopathy
Novartis secures FDA approval for Fabhalta, the first-ever treatment for C3G. Find out how this breakthrough impacts patients and investors.
Novartis reports significant proteinuria reduction by Fabhalta in Phase 3 IgAN trial
Novartis has shared encouraging results from the Phase III APPLAUSE-IgAN study, revealing that Fabhalta (iptacopan) led to a…