First CGRP Migraine Treatment Under FDA Review
The FDA is reviewing the BLA for Aimovig for migraine prophylaxis.
Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Aimovig (erenumab) for migraine prophylaxis in patients experiencing ≥4 migraine days per month.
The BLA contains supporting data from Phase 2 and Phase 3 clinical studies (n >2600) of patients experiencing ≥4 migraine days per month. Clinical studies comparing Aimovig and placebo showed a decrease in the number of migraine-affected days, disability, and acute medication use for patients with episodic and chronic migraine.
Regarding safety, Aimovig exhibited a comparable profile with placebo for all study treatment arms for up to 6 months. The most frequent adverse events were upper respiratory tract infection, injection site pain, nausea, and nasopharyngitis.
If approved by the FDA, Aimovig will be the first monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor specifically intended for migraine prophylaxis. CGRP is thought to be causally involved in migraine pathophysiology.
The FDA's Prescription Drug User Fee Act (PDUFA) target date has been set for May 17, 2018. Aimovig will be commercialized by Amgen and Novartis.
FDA Accepts Biologics License Application For Aimovig™ (erenumab) [news release]. Amgen newsroom: July 20, 2017. http://www.amgen.com/media/news-releases/2017/07/fda-accepts-biologics-license-application-for-aimovig-erenumab/