AMG 334 (erenumab) filed with FDA for migraine- Amgen
Amgen announced the submission of a Biologics License Application to the FDA for AMG 334 (erenumab) to prevent migraine. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor.
This BLA includes data from pivotal studies in patients with episodic and chronic migraine. The erenumab global clinical trial program has enrolled more than 2,600 patients experiencing four or more migraine days per month, with some patients receiving erenumab for up to three years. Results from the chronic migraine study were published in The Lancet Neurology in April 2017 and detailed results from Phase III in episodic migraine have been submitted for publication.
Results from the pivotal studies, investigating the efficacy of erenumab versus placebo in reducing the number of migraine days for patients with episodic and chronic migraine, will be presented during the 59th Annual Scientific Meeting of the American Headache Society.
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