Amgen (AMGN) Migraine Drug Hits Phase III Primary Endpoint

Amgen Inc. (NASDAQ:AMGN) announced positive top-line data from a phase III study (ARISE) on calcitonin gene-related peptide (CGRP) receptor, erenumab (AMG 334), for the prevention of episodic migraine.

The multi-center, randomized, 12-week, double-blind, placebo-controlled study evaluated the safety and efficacy of erenumab in patients with episodic migraine. Data showed that patients, when treated with erenumab (70 mg), experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, in comparison to a 1.8-day reduction in the placebo arm at 12 weeks, thereby meeting the primary endpoint of the study. In addition, the safety profile of erenumab was found to be similar to placebo and consistent with previously reported studies.

Currently, additional analyses of these data are in progress and expected to be submitted at a future medical conference and for publication.

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Earlier this year, positive data from a phase II study on erenumab for the prevention of chronic migraine were also announced. Meanwhile, the candidate is also being evaluated in a second phase III episodic migraine study (STRIVE), assessing both 70 mg and 140 mg doses for 24 weeks. The study is anticipated to be completed by the end of this year.

We note that, Amgen is developing erenumab in collaboration with Novartis AG (NYSE:NVS) , focused on the development and commercialization of treatments for migraine and Alzheimer's disease. For the migraine program, Amgen owns commercialization rights in the U.S., Canada and Japan, while Novartis has rights in Europe and Rest of World.

We note that several companies, including Teva Pharmaceutical Industries Limited (NYSE:TEVA) and Allergan plc (NYSE:AGN) among others, are developing migraine treatments targeting CGRP.

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