Novartis Receives European Commission Approval for Fabhalta in Paroxysmal Nocturnal Hemoglobinuria

Novartis today announced that the European Commission has approved Fabhalta (iptacopan) as the first oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH) in the European Union. The approval was based on the same pivotal APPLY-PNH trial data that supported the FDA approval, demonstrating superior efficacy compared to anti-C5 therapy. This approval makes Fabhalta available to PNH patients across all EU member states. Novartis is committed to ensuring broad patient access to Fabhalta in Europe and continues to study iptacopan in other complement-mediated diseases.