Posted by Michael Wonder on 22 Mar 2024
Novartis Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria
22 March 2024 - Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior haemoglobin improvement in the absence of transfusions with Fabhalta compared to anti-C5 therapy.
Novartis announced today that the CHMP of the EMA has adopted a positive opinion and recommended granting a marketing authorisation for Fabhalta (iptacopan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have haemolytic anaemia.
