Biologic for Migraine Prevention Submitted to FDA

The submission is based on data from a set of global, pivotal, placebo-controlled studies
The submission is based on data from a set of global, pivotal, placebo-controlled studies

Amgen announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for erenumab for the prevention of migraines.

The BLA submission is supported by data from the erenumab global clinical trial program, a set of pivotal studies evaluating the efficacy of erenumab vs. placebo in reducing the number of migraine days for patients with episodic or chronic migraine. Data from the chronic migraine studywere published  in The Lancet Neurology in April 2017 and detailed findings from the episodic migraine study have been submitted for publication. Results from these studies will also be presented at the 59th Annual Scientific Meeting of the American Headache Society in June 2017. 

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Erenumab is a fully human monoclonal antibody designed to specifically inhibit the Calcitonin-Gene-Related-Peptide (CGRP) receptor, a neuropeptide that has long been postulated to play an integral role in migraine pathophysiology.

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