Migraine Drug Demonstrates Efficacy in Patients with Multiple Treatment Failures

Amgen’s erenumab (Aimovig) achieved positive results in the first-of-its-kind phase 3b LIBERTY trial for the treatment of patients with episodic migraines who had previously failed 2 to 4 preventive treatments, according to a press release.

LIBRTY is the first study to investigate a treatment targeting the calcitonin gene-related peptide (CGRP) pathway specifically in this patient population, according to the press release.

The trial included 246 patients who had experienced 2 to 4 previous preventive treatment failures. The patients were randomized to receive monthly subcutaneous injections of either erenumab 140 mg or placebo for 12 weeks.

According to the data, patients treated with erenumab had nearly 3-fold higher odds of having their migraine days cut by at least 50%. More than twice as many patients taking erenumab achieved this reduction compared with placebo.

Erenumab is currently the only investigational fully human monoclonal antibody under regulatory review that was designed to selectively block the CGRP receptor, which plays a role in migraine activation, according to Amgen.

In the study, patients taking erenumab showed statistically significant and clinically meaningful improvements from baseline across all secondary endpoints, such as reduction in monthly migraine days, decrease in monthly 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.

“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,” Uwe Reuter, MD, managing medical director at Charité Universitätsmedizin in Berlin, said in the press release.

More than 97% of patients treated with erenumab completed the double-blind phase of the LIBERTY study, according to the press release. There were no adverse events leading to discontinuation.

The long-term open label extension phase of the study is ongoing. According to the press release, the FDA has set a prescription drug user fee act target action date of May 17, 2018 for erenumab.

Even more resources pertaining to headaches and migraines can be found on Specialty Pharmacy Times' new sister site, NeurologyLive.

Reference

Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig™ (erenumab) For Migraine Patients With Multiple Treatment Failures [news release]. Amgen’s website. https://www.amgen.com/media/news-releases/2018/04/amgen-presents-firstofitskind-data-at-aan-annual-meeting-reinforcing-robust-and-consistent-efficacy-of-aimovig-erenumab-for-migraine-patients-with-multiple-treatment-failures/ Accessed April 20, 2018.