Novartis announced FDA approval for Fabhalta

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Go back to Novartis announced FDA approval for Fabhalta

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

December 6, 2023 12:19 AM EST

Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement inhibitor-naïve patients1-5 In APPLY-PNH, patients who switched to Fabhalta experienced superior increases of hemoglobin levels 2 g/dL (82.3% vs. 0%) and hemoglobin level 12 g/dL (67.7% vs. 0%), both in the absence of red blood cell transfusions, vs. patients who continued on anti-C5 treatment1,2 Fabhalta, now available for both previously treated and treatment-naïve patients, is the only FDA-approved Factor B inhibitor of the... More