Patients with hard-to-treat episodic migraine experienced marked improvement in the phase 3B LIBERTY study of erenumab (Aimovig, Amgen), according to new trial results.
The study assessed the efficacy and safety of erenumab 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 erenumab experiencing at least a 50% reduction from baseline in their monthly migraine days compared with 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 (MPFID) 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 erenumab to date. Full data will be presented at an upcoming scientific meeting.
Erenumab is the only investigational fully human monoclonal antibody designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. These results are the first positive placebo-controlled data to be reported in an episodic patient population consisting entirely of those who have tried and failed two to four preventive medications due to lack of efficacy or intolerable side effects.
"These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig," said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.
The safety, efficacy, and tolerability of erenumab have been assessed in more than 3,000 patients, including an ongoing open-label extension of up to five years in duration. The FDA has set a Prescription Drug User Fee Act (PDUFA) 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.
LIBERTY (NCT03096834) is a multicenter, randomized, 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of erenumab in patients with episodic migraine (defined in the trial as four to 14 migraine days per month at baseline) who have failed up to four prior preventive treatments for migraine. In the study, 246 participants with episodic migraine who had two to four previous treatment failures were randomized to receive erenumab 140 mg or placebo during the 12-week double-blind treatment phase. The primary endpoint was the%age of patients with at least a 50% reduction of monthly migraine days from baseline over the last four weeks of the double-blind treatment phase of the study (weeks 9–12). The study includes an ongoing 52-week open-label extension study.
Source: Amgen; January 23, 2018.