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news.Amgen has submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab to prevent migraine.
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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.
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said: "People with migraine lose a substantial part of their lives enduring or managing the disease, which takes time away from their loved ones, social activities and workplace responsibilities. Approximately 3.5 million Americans currently take a preventive treatment to reduce their number of migraine days, yet 80 percent of those discontinue these treatments within one year.
"This application represents a long-awaited step towards addressing the unmet need faced by the migraine community through the potential delivery of erenumab, which has demonstrated strong efficacy, safety and tolerability 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 3 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 in Boston this June.
Erenumab is a human monoclonal antibody specifically designed for the prevention of migraine. Erenumab specifically inhibits the receptor of the Calcitonin Gene-Related Peptide (CGRP), which has been thought to play a causal role in migraine pathophysiology.
Erenumab has been studied in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention.