Posted by Michael Wonder on 30 Jul 2017
FDA accepts biologics license application for Aimovig (erenumab)
20 July 2017 - Aimovig is an Investigative migraine-specific preventive therapy designed for patients with high unmet need.
Amgen today announced that the U.S. FDA has accepted for review the biologics license application for Aimovig (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, Aimovig is expected to be the first-and-only monoclonal antibody targeting the calcitonin gene-related peptide receptor, specifically designed for the prevention of migraine.
The FDA has set a Prescription Drug User Fee Act target action date of 17 May 2018.
