Alexion Pharma: CHMP Adopts Positive Opinion For New Advanced Formulation Of ULTOMIRIS
(RTTNews) - 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.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.