Amgen announced sub-analysis results from their Phase 2 trial of Aimovig (erenumab) which found that monthly migraine days (MMDs) were significantly reduced with Aimovig when compared to placebo in patients who failed ≥2 prior preventive treatments. The study results were presented at the 18th Congress of the International Headache Society being held in Vancouver, Canada.

Aimovig is an investigational biologic product designed to prevent migraine by blocking the calcitonin gene-related peptide (CGRP) receptor. The Phase 2 study (“20120295 study”), which included 667 patients, was a double-blind, placebo-controlled trial with doses administered once monthly. Results showed that at the end of the 12-week trial participants in the Aimovig 140mg group had a reduction of 7 MMDs and the 70mg group had a reduction of 5.4 days, while the placebo group had a reduction of 2.7 days (P<0.001).

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Furthermore, Amgen conducted a cardiovascular safety study (“20140254 study”) of Aimovig. The study met it primary endpoint of noninferiority, showing no difference in exercise time among participants receiving Aimovig or placebo. In addition, no significant differences were seen between the two groups in time to onset of angina or time to onset of electrocardiogram change consistent with onset of myocardial ischemia.

“The results of this [safety] study provide some evidence that CGRP receptor inhibition did not aggravate myocardial ischemia in at-risk population of patients with stable angina compared to placebo and contribute to the growing body of evidence supporting the safety profile of Aimovig,” said Amaal J. Starling, MD, at Mayo Clinic AZ, and co-author of the study.

The Food and Drug Administration (FDA) accepted for review the Biologics License Application for Aimovig in July. A Prescription Drug User Fee Act (PDUFA) target action date has been set for May 17, 2018.

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