28 February 2025 - If approved, Fabhalta will be the only medicine indicated to selectively target the underlying cause of C3G, an ultra rare, progressive kidney disease with no currently approved treatments.
Novartis announced today that the CHMP of EMA has adopted a positive opinion and recommended granting a marketing authorisation for Fabhalta (iptacopan) – a first in class oral Factor B inhibitor of the alternative complement pathway – for the treatment of adults with C3 glomerulopathy.