Posted by Michael Wonder on 06 Dec 2023
Novartis receives FDA approval for Fabhalta (iptacopan), offering superior haemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH
6 December 2023 - Approval based on APPLY-PNH trial in adults with PNH and anaemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement inhibitor-naïve patients.
Novartis today announced that the US FDA approved Fabhalta (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal haemoglobinuria.
