Amgen and Novartis' Aimovig shines in migraine at Phase 3

Amgen has lifted the curtain on complete Phase 3 data for its calcitonin gene-related peptide receptor (CGRP) inhibitor Aimovig (erenumab) in the treatment of episodic migraine in patients who had previously failed two to four preventive treatments, whether due to ineffectiveness or intolerable side effects.

In the trial, 246 patients were randomised to receive either monthly subcutaneous injections of either 140mg Aimovig or placebo for 12 weeks. It was found that the group taking Aimovig were almost three times more likely to have their migraine days cut by at least 50%; more than twice as many patients in this group achieved this reduction compared to the placebo group, with 30.3% in the former and 13.7% in the latter.

Amgen also said that the Aimovig group experienced “clinically meaningful” improvements from baseline in all secondary endpoints compared to placebo, including: reduction in monthly migraine days; decrease in monthly acute migraine-specific drug use; 75% or greater reduction in monthly migraine days; and 100% reduction in monthly migraine days.  

“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 from currently available preventive treatment options,” said Professor Uwe Reuter, Managing Medical Director at Charité Universitätsmedizin in Berlin. “These compelling 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.”

According to the manufacturer, Aimovig is the only fully human monoclonal antibody under regulatory review that selectively blocks the CGRP receptor. Under the terms of an agreement struck by Amgen with Novartis, should Aimovig secure approval, the pair will co-commercialise the drug in the US; Amgen holds exclusive rights in Japan while Novartis will handle commercialisation in the rest of the world.

“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 Dr Sean E Harper, Executive Vice President of Research and Development at Amgen. “These data support the overall efficacy and safety profile we have seen consistently during extensive clinical study of Aimovig, and speak to its potential to help fill treatment gaps in more difficult patient populations whose migraine has not been adequately managed with current therapies.”

Matt Fellows