Amgen: Aimovig met all primary, secondary endpoints in Phase 3b LIBERTY study
Amgen announced positive results from the Phase 3b LIBERTY study assessing the efficacy and safety of Aimovig 140 mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects. The study met its primary endpoint, with significantly more patients taking Aimovig experiencing at least a 50% reduction from baseline in their monthly migraine days as compared to placebo. LIBERTY also met all secondary endpoints, including reduction of monthly migraine days, reduction in days needing acute (rescue) medication, improvement in scores on the Migraine Physical Function Impact Diary tool, and 75% and 100% responder rates (number of patients experiencing at least a 75% or 100% reduction in monthly migraine days compared to placebo). The safety data are consistent with previous studies of Aimovig to date. Full data will be presented at an upcoming scientific meeting. The safety, efficacy and tolerability of Aimovig have been assessed in more than 3,000 patients, including an ongoing open-label extension of up to five years in duration. Aimovig was the first investigational therapy targeting the CGRP pathway to receive U.S. FDA and European Medicines Agency regulatory filing acceptance. The FDA has set a Prescription Drug User Fee Act target action date of May 17, 2018. If approved, it will be administered once-monthly using a self-injection device. If approved, Novartis and Amgen will co-commercialize Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in rest of world.