Amgen Releases Positive Results from Phase 3 ARISE Study
Amgen has released information regarding their Phase 3 ARISE study, indicating that the study has met its primary endpoints. The study centers around a new treatment co-developed by both Amgen and Novartis for episodic migraines. The study was double-blind, multicenter, and placebo-controlled. 577 individuals with episodic migraine were given either placebo or 70 mg of Erenumab subcutaneously once a month, for 12 weeks. All of the individuals who participated in the study had episodic migraines and experienced between four and 14 migraine days per month at baseline.
The primary endpoint of the study, to achieve a statistically significant reduction of migraine days from baseline for individuals with episodic migraine, was reported to have been met. Those receiving Erenumab experienced a 2.9-day decrease in monthly migraine days from baseline, whereas those receiving placebo only experienced a 1.8-day reduction. This difference in outcome was reported to be statistically significant, and indicate that those on the medication, on average, suffered from less migraine days monthly than their non-treated counterparts. The most common side effects of the medication included injection site pain, nasopharyngitis, and upper respiratory infections.
The new drug is a human monoclonal antibody, that works to block the calcitonin gene-related peptide (CGRP) receptor. This receptor is thought to play a role in the onset and excruciating pain of migraine. Erenumab was produced as a result of Amgen and Novartis’ August 2015 initiative to join together in order to explore more treatment options for migraine and Alzheimer’s disease. The initiative is currently running the Phase 3 STRIVE study which is investigating both the 70 mg and 140 mg dosages of Erenumab over a 24-week period. The results for this study should be out by the end of this year.
"People with episodic migraine lose a substantial part of their lives to migraine, and many face intolerable pain and physical impairment, frequently accompanied by a significant disruption of their daily activities. Unfortunately, there are limited preventive treatment options currently available for these patients. These positive results, along with the recent chronic migraine results, contribute to the growing body of evidence supporting Erenumab as an innovative treatment option for people who are suffering from this debilitating disease." -Sean E. Harper, MD, Executive Vice President of Research and Development at Amgen
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