Alexion Receives Early FDA Approval For ULTOMIRIS™ (Ravulizumab-Cwvz) In Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
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“This approval is based on comprehensive results from two Phase 3 studies, which were recently published in Blood.In these studies, which included 441 patients who had either never been treated with a complement inhibitor before, or who had been stable on SOLIRIS, the efficacy of ULTOMIRIS administered every eight weeks was non-inferior to the efficacy of SOLIRIS administered every two weeks on all 11 endpoints.”