With a PDUFA date of May 17 looming, Amgen and Novartis’ migraine drug has hit its primary and secondary endpoints in a phase 3b study involving migraine patients for whom multiple other therapies have not worked.
The LIBERTY study investigated the safety and efficacy of Aimovig (erenumab), a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) pathway, in patients with episodic migraine who have failed on two to four preventive treatments.
The treatment is designed for once-monthly delivery via a self-injector. If approved, Amgen and Novartis will co-commercialize Aimovig in the U.S., while Amgen has rights to the treatment in Japan and Novartis will market it in the rest of the world.
The study met its primary endpoint, with more patients on Aimovig experiencing 50% fewer monthly migraine days than baseline when compared to placebo, according to a statement. It also hit its secondary endpoints, including reduction of monthly migraine days, reduction in days needing rescue medication and improved scores on the Migraine Physical Function Impact Diary (MPFID) tool.
The data come nearly a year after the companies unveiled results from a pair of phase 3 trials. Although not “overwhelmingly positive,” according to Leerink analysts, the candidate did beat out placebo in cutting monthly migraine days and left “no doubt that erenumab will receive regulatory approval.”
"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," said Sean Harper, M.D., R&D chief at Amgen, in the statement. "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."
A handful of other players are racing to get their CGRP meds to market—Eli Lilly reported promising data from a trio of phase 3 trials last summer, and Teva and Alder BioPharmaceuticals both have contenders in the clinic. Amgen and Novartis may have a slight lead now, but Lilly and Teva aren’t far behind, with the FDA approving the BLA for their respective candidates in December.
"We're in a genuine watershed moment with the very first class of migraine treatments that can prevent the attacks from actually happening," said Peter Goadsby, a neurologist at King's College London and the University of California, San Francisco, commenting on the four CGRP inhibitors leading the race on which data were presented at the 2017 meeting of the American Headache Society.