Amgen’s Phase 3b study called Liberty, in co-development with Novartis, aimed to test Aimovig for treating migraine, has met it’s main goal, which was to get patients to have at least half as less migraine days as compared to placebo.
According to Amgen’s Monday press release, the study has also met all its secondary endpoints, such are reducing the monthly number of migraine days and the need to take rescue medications. It has shown improvement in scores on the Migraine Physical Function Impact Diary (MPFID) tool, and 3/4 to 1% responder rates compared to placebo.
Amgen said that the safety data are consistent with previous studies of Aimovig to date, and that the full data will be presented at an upcoming scientific meeting.
Aimovig is the only investigational fully human monoclonal antibody, designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. These results are the first positive placebo-controlled data ever reported in an episodic patient population consisting entirely of those who have tried and failed two to four preventive medications due to lack of efficacy or intolerable side effects.
Sean E. Harper, executive vice president of Research and Development at Amgen, said: “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. 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. We look forward to working with regulators to bring the first preventive option specifically developed for migraine to patients worldwide.”
“The LIBERTY trial is the only Phase IIIb anti-CGRP study to demonstrate safety and efficacy in patients who have repeatedly failed other preventive treatments,” said Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis. “The results add to the consistent body of evidence for erenumab across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years. We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible.”
Image: An Amgen sign is seen at the company’s office in South San Francisco, California October 21, 2013. REUTERS/Robert Galbrait