Novartis presents new 48-week results from Phase III APPLY-PNH trial showing sustained efficacy and long-term safety of Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH)

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  • APPLY-PNH extension data show that continuous Fabhalta® (iptacopan) treatment in adults with paroxysmal nocturnal hemoglobinuria (PNH) enabled sustained hemoglobin-level increases to near-normal (≥12 g/dL), blood transfusion avoidance, and improved patient-reported fatigue in the majority of patients, with a safety profile consistent with previously reported data1-5
  • Patients switching from anti-C5s to Fabhalta in the extension period achieved outcomes comparable to the Fabhalta arm in the 24-week randomized controlled period, including transfusion avoidance and near-normal hemoglobin-levels (≥12 g/dL) in the majority of patients1
  • Fabhalta was recently approved by the FDA for adults with PNH, including for both previously treated and treatment-naive patients6

EAST HANOVER, N.J., Dec. 10, 2023 /PRNewswire/ -- Novartis today announced results from the extension period of the pivotal Phase III APPLY-PNH trial of oral monotherapy Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) who had residual anemia (hemoglobin

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