Amgen (AMGN) Announces Erenumab Phase 3 Met Primary Endpoint as Migraine Treatment
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Amgen (Nasdaq: AMGN) announced positive top-line results for erenumab from a global Phase 3, randomized, double-blind, placebo-controlled STudy to evaluate the efficacy and safety of erenumab in migRaIne preVEntion (STRIVE). These data showed the STRIVE study met the primary endpoint, demonstrating statistically significant reductions from baseline in monthly migraine days in patients with episodic migraine treated with either 70 mg or 140 mg erenumab compared with placebo. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor, which is believed to have a critical role in mediating the incapacitating pain of migraine.
"Migraine is ranked one of the most debilitating diseases by the World Health Organization, yet it is often under-diagnosed and under-treated. People who experience migraine battle the disease for many years and it has significant impact on their everyday activities," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The results of this study are important because they confirm the results from our previous studies and add to our body of research in episodic migraine. We look forward to working with regulatory authorities to pursue approval of erenumab and making this novel migraine prevention treatment available to patients and physicians."
Patients enrolled in STRIVE were randomized to receive either placebo, or one of two erenumab doses – 70 mg or 140 mg – subcutaneously, once monthly for six months. At baseline, patients were experiencing an average of 8.3 migraine days per month. Patients in the erenumab 70 mg and 140 mg treatment arms experienced reductions of 3.2 and 3.7 days from baseline in monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.These results were statistically significant.
The safety profile of erenumab was comparable to placebo across both treatment arms and was consistent with previously reported studies. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and sinusitis.
Further analysis of STRIVE data is ongoing and will be submitted to a future medical conference and for publication.
Two other positive trials—ARISE, a Phase 3 study of erenumab in episodic migraine prevention, and the Phase 2 study of erenumab in chronic migraine prevention—were announced earlier this year. Combined together, almost 2,200 patients with chronic and episodic migraine have participated in these three erenumab clinical trials. These data will help support discussions with regulatory agencies, with filing anticipated in 2017.
Erenumab is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and rest of world.
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