Amgen announced that Aimovig (erenumab) 140mg met its primary endpoint in the LIBERTY study, demonstrated by significantly more Aimovig-treated patients experiencing a ≥50% reduction from baseline in their monthly migraine days vs placebo.
The Phase 3b, multicenter, randomized, 12-week, double-blind, placebo-controlled study (n=246) evaluated the safety and efficacy of Aimovig in patients with episodic migraine who had experienced 2 to 4 previous preventive treatment failures, due to lack of efficacy or intolerable side effects.
The primary endpoint was the percentage of patients with ≥50% reduction of monthly migraine days from baseline over the last 4 weeks of the double-blind treatment phase of the study (Weeks 9 through 12).
In addition, all of the secondary endpoints were met, including the reduction of monthly migraine days, reduction in days needing rescue medication, improvement in scores on the Migraine Physical Function Impact diary (MPFID) tool, and 75% and 100% responder rates. The safety profile of Aimovig was consistent with previous studies. The full findings will be presented at a future scientific meeting.
Aimovig, a fully human monoclonal antibody, works by selectively blocking the calcitonin gene-related peptide (CGRP) receptor, which is involved in migraine activation.
The LIBERTY study also has a 52-week open-label extension study that is ongoing. “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,” stated Sean E. Harper, MD, executive VP of Research and Development at Amgen.
The FDA has set a target Prescription Drug User Fee Act (PDUFA) action date of May 17, 2018.
Amgen reports Aimovig™ (erenumab) met all primary and secondary endpoints in unique phase 3b study in episodic migraine patients who have failed multiple prior preventive treatments [press release]. Thousand Oaks, CA: PR Newswire; January 22, 2018. Accessed February 14, 2018.
This article originally appeared on MPR