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.  

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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. 

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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.

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