Amgen (AMGN) Submits BLA to FDA for Migraine Drug Erenumab
Amgen Inc. AMGN recently announced the submission of a biologics license application (BLA) to the FDA for its pipeline candidate erenumab (AMG 334) for the prevention of migraine.
Shares of Amgen have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has gained 8% during the period, while the broader industry witnessed an increase of 1.1%.
The BLA submission was supported by positive data from pivotal studies in patients with episodic and chronic migraine. The studies were designed to assess the drug’s safety and efficacy in migraine prevention. In Sep 2016, the company announced positive top-line data from the first pivotal phase III study (ARISE) on erenumab for the prevention of episodic migraine. Meanwhile, the candidate is being evaluated in a second phase III episodic migraine study (STRIVE), assessing both 70 mg and 140 mg doses for 24 weeks. In Nov 2016, the company announced positive top-line data from the study.
Moreover in Jun 2016, positive data from a phase II study for the prevention of chronic migraine were also announced. Results from the studies will be presented at American Headache Society in Boston in June.
We remind investors that Amgen is developing erenumab in collaboration with Novartis AG NVS. The companies are focused on the development and commercialization of the treatments for migraine and Alzheimer's disease. For the migraine program, Amgen retains commercialization rights in Japan, while Novartis has rights in Europe, Canada and Rest of World.
We note that several companies, including Teva Pharmaceutical Industries Limited TEVA and Allergan plc AGN, are developing migraine treatments targeting CGRP.
Per the company’s press release, around 10 million people in the U.S. are affected by migraine. Among them, approximately 3.5 million of these patients are currently on a preventive therapy with 80% of them likely to discontinue the treatment within one year. Thus, approval of the drug will address the huge unmet need faced by patients suffering from the disease in the U.S.
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Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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