Alexion Pharmaceuticals, Inc. (ALXN) announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending marketing authorization in the European Union for a new 100 mg/mL intravenous advanced formulation of ULTOMIRIS (ravulizumab). The company noted that the European Commission typically reaches a decision on approval in approximately two months of the CHMP recommendation.
ULTOMIRIS is the first and only long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare diseases—paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
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