Amgen, Novartis Announce Positive Results of Erenumab Trial for Episodic Migraine

Amgen and Novartis announced full results from the Phase 3b LIBERTY trial, which assessed erenumab (Aimovig) as preventive treatment for patients with episodic migraine who had previously failed on other treatments.

Erenumab is the only fully human monoclonal antibody under regulatory review for the selective blocking of the calcitonin gene-related peptide (CGRP) receptor, and LIBERTY is the first study to investigate a treatment targeting the CGRP pathway in this patient population, according to a release from Amgen.

“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, research and development, Amgen, in a statement.

The study included 246 patients who had previously been treated with 2 to 4 treatments. Participants were randomized 1:1 to receive monthly subcutaneous injections of either 140 mg of erenumab or placebo for 12 weeks. The primary endpoint was the proportion of patients experiencing a 50% or greater reduction in mean monthly migraine days during weeks 9 through 12.

At baseline, the proportion of patients who failed 2, 3, and 4 previous treatments were 38.6%, 37.8%, and 22.8%, respectively. Results showed that those taking erenumab had nearly three-fold higher odds of having their migraine days reduced by at least 50% (30.3% versus 13.7%). Safety and tolerability was comparable to placebo, and no patients in the erenumab cohort discontinued due to adverse events.

The erenumab cohort also had statistically significant improvements from baseline compared to placebo across all secondary endpoints, including:

• Reduction in monthly migraine days
• Decrease in acute migraine-specific drug use
• 75% or greater reduction in monthly migraine days
• 100% reduction in monthly migraine days
• Improved physical functioning and ability to complete everyday activities as measured by the Migraine Physical Function Impact Diary scales

“The LIBERTY study distinctively demonstrates the ability of an anti-CGRP receptor antibody to significantly reduce migraine frequency and its associated burden in patients who could not find the relief they need with the currently available preventive treatment options,” said Uwe Reuter, MD, managing medical director, Charité Universitätsmedizin, and a co-author of the study, in a press release from Novartis. “These compelling new data offer new hope of fewer migraine days to those people with migraine who may have cycled through current standard of care unsuccessfully for years due to lack of efficacy and tolerability.”

The data will be presented next week at the 70th Annual Meeting of the American Academy of Neurology in Los Angeles, California.