Amgen announced that its Phase 3 trial of Aimovig (erenumab) found that the investigational treatment reduced monthly migraine days by 3.2 for patients who experienced a mean baseline of 8.3 monthly migraine days.
A total of 955 patients took part in the STRIVE study, and they were randomized to receive placebo or subcutaneous Aimovig 140mg or 70mg once monthly for 6 months.
The 140mg group had a 3.7-day reduction in monthly migraine days vs. a 3.2-day reduction for the 70mg dose group and a 1.8-day reduction for the placebo group. Migraine days were cut by ≥50% for half of the patients in the 140mg group, by 43.3% for the 70mg group, and by 26.6% for the placebo group.
Aimovig also showed superiority in the secondary endpoint with a significant reduction in the number of days per month a rescue medication was needed compared to placebo: 1.6 days for 140mg, 1.1 days for 70mg, and 0.2 days for the placebo group (P<0.001). In addition, patients treated with Aimovig had clinically meaningful benefits with a reduction in the impact of migraine on their everyday activities such as getting ready for the day, or household chores or activities requiring concentration: 5.9 points for 140mg, 5.5 points for 70mg, and 3.3 points for placebo (P<0.001).
The Company recently released Phase 2 study results which had similar outcomes. The trial, which examined cardiovascular safety of Aimovig, found no significant differences between the treatment and placebo groups in time to onset of angina or time to onset of electrocardiogram changes consistent with onset of myocardial ischemia.
“Publication of these data underscores the significance of the CGRP receptor blocker Aimovig as potentially the first available treatment targeting a pathophysiologically relevant pathway for one of the most common causes of disability across the globe,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.
Aimovig is an investigational biologic product intended to prevent migraine by blocking the calcitonin gene-related peptide (CGRP) receptor. A New Drug Application (NDA) for Aimovig has been filed with the Food and Drug Administration and a Prescription Drug User Fee Act (PDUFA) target date of May 17, 2018 has been set.
For more information visit Amgen.com.