Alexion Pharmaceuticals reports that the pivotal Phase 3 study of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, demonstrated non-inferiority to Soliris® (eculizumab) in complement inhibitor treatment-naïve patients with paroxysmal nocturnal hemoglobinuria based on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase levels, a direct marker of complement-mediated hemolysis in PNH.

The study also demonstrated non-inferiority on all four key secondary endpoints: percentage change from baseline in LDH levels, change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale, proportion of patients with breakthrough hemolysis, and proportion of patients with stabilized hemoglobin levels. In addition, numeric results for all six endpoints favored ALXN1210.

There were no notable differences in the safety profiles for ALXN1210 and Soliris®.