Amgen and Novartis Reach an Important Milestone

The migraine drug, Aimovig, meets its endpoints in a phase 3b study.

The safety and efficacy of Aimovig (erenumab) has been confirmed in a clinical trial. Known as the LIBERTY study, the trial was intended for migraine headache sufferers who were unresponsive to other therapies; specifically, patients had episodic migraines for whom two to four preventive treatments had already failed, either due to a lack of effectiveness or inability to tolerate the side effects.

Aimovig is a monoclonal antibody, which works by targeting the calcitonin gene-related peptide (CGRP) pathway. The therapy is available as a once-monthly treatment that patients are able to self-administer via injection; it is a preventative treatment.

The therapy was able to meet its primary endpoints during the randomized 12-week, double-blind LIBERTY study. A greater number of patients who were given Aimovig experienced 50% fewer monthly migraine days than baseline, when compared to patients who were only given a placebo. All secondary endpoints were also met, with patients from the study claiming the following improvements: a 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 percent and 100 percent responder rates (number of patients experiencing at least a 75 percent or 100 percent reduction in monthly migraine days compared to placebo). Safety findings from the trial are consistent with prior performance and will be made fully available at an upcoming scientific meeting, according to the press release.

Sean Harper, M.D., R&D Chief at Amgen commented on the outcome of the trial. "We've purposely designed a clinical program for Aimovig that examined a broad spectrum of migraine patients, ranging from those who have never tried a preventive treatment to patients who have tried and failed such treatments," he commented. "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 Harper. 

More than 3,000 patients were assessed for the safety, efficacy and tolerability of Aimovig. Aimovig is the first investigational therapy to target the CGRP pathway that has received U.S. Food and Drug Administration (FDA) and European Medicines Agency regulatory filing acceptance.

If the therapy meets all anticipated approvals, Amgen and Novartis will co-commercialize Aimovig in the U.S., while Amgen has rights to the treatment in Japan, while Novartis will market it in the rest of the world.

 

Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.

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