Results from Phase 3 Trial of Erenumab for Migraine
Results were announced today from the phase 3b LIBERTY trial treating patients with migraine who have not had relief from 2 to 4 other treatment options with erenumab (provisionally approved as Aimovig; Amgen, Thousand Oaks, CA). This population of patients with episodic migraine and a history of failed treatments is a difficult-to-treat population often excluded from migraine prevention trials.
Erenumab is an investigational fully human monoclonal antibody, under regulatory review, designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. LIBERTY is the first study to investigate a treatment targeting the CGRP pathway specifically in this challenging patient population.
Results include a safety and tolerability trial that is consistent with results seen in the pivotal clinical program, with more than 90% of subjects completing the double-blind treatment phase. In the LIBERTY trial, 246 patients, who had experienced 2 to 4 preventative treatment failures, were randomized to receive a monthly subcutaneous injection of 140 mg erenumab or a placebo for 12 weeks. Patients taking erenumab had nearly 3 times higher odds than those taking placebo of having 50% fewer migraine days compared to pretreatment baselines. Twice as many patients taking erenumab achieved the reduction of 50% or more than those taking placebo (weeks 9-12: 30.3% with erenumab, 13.7% with placebo, P<0.002, odds ratio 2.73).
“We are encouraged by these new findings, which add to the growing body of clinical evidence supporting potential use of Aimovig across a broad spectrum of patients with migraine, all of whom live with what is considered one of the most disabling diseases,” said Sean E. Harper, MD, Executive Vice President of Research and Development at Amgen.