Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH | Novartis

Novartis announced FDA approval of Fabhalta® (iptacopan) as the first oral monotherapy for adults with PNH, showing superior hemoglobin level increases and transfusion avoidance in trials. Fabhalta, a Factor B inhibitor, addresses unmet needs in PNH treatment, offering a new option for patients previously treated with anti-C5 therapies.