FDA accepts filing of ALXN 1210 to treat paroxysmal nocturnal hemoglobinuria.- Alexion Pharma.
Alexion Pharmaceuticals, Inc.v announced that the FDA has accepted for review the Company�s Biologics License Application (BLA) for approval of ALXN 1210, the Company�s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
The FDA set a Prescription Drug User Fee Act (PDUFA) date of February 18, 2019 , as part of an expedited eight-month review instead of the standard 12-month review following Alexion�s use of a rare disease priority review voucher. The application is supported by comprehensive data from two rigorous Phase III clinical trials.
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