Superior Hb improvements were achieved with FABHALTA over C5is
PRIMARY END POINTS
Significantly more patients achieved Hb improvements in the absence of RBC transfusions with FABHALTA vs C5is1
Patients with Hb increase of ≥2 g/dL* from baseline in the absence of RBC transfusions† after 24 weeks
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*Assessed between Days 126 and 168.1
†Assessed between Days 14 and 168. Requiring RBCs refers to any patient receiving transfusions or meeting protocol-defined criteria.2
‡Adjusted difference in proportion.1
Patients with normalized§ Hb of ≥12 g/dL* in the absence of RBC transfusions† after 24 weeks
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*Assessed between Days 126 and 168.1
†Assessed between Days 14 and 168. Requiring RBCs refers to any patient receiving transfusions or meeting protocol-defined criteria.2
‡Adjusted difference in proportion.1
§Normalization defined as meeting the primary end point of Hb ≥12 g/dL.2 Normal Hb levels vary, but generally are between 12-16 g/dL for women and 13-18 g/dL for men.3
FABHALTA is the first PNH treatment to evaluate a primary end point of the response rate of patients achieving sustained Hb increase of ≥2 g/dL, as opposed to Hb stabilization1,4-6