Posted by Michael Wonder on 21 Aug 2018
FDA accepts priority review of ALXN1210 as a treatment for patients with paroxysmal nocturnal haemoglobinuria in the US
20 August 2018 - EU filing accepted and under review.
Alexion Pharmaceuticals announced today that the U.S. FDA has accepted for review the Company’s biologics license application for approval of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal haemoglobinuria.
The FDA set a Prescription Drug User Fee Act date of 18 February 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 3 clinical trials.
