Amgen's Migraine Drug Heads Toward Possible May Approval

Amgen announced final data from its Phase IIIb LIBERTY clinical trial of Aimovig (erenumab), with positive results likely to lead to a blockbuster drug for migraine sufferers.

Aimovig decreased migraine days by about 50 percent in about a third of patients receiving it. In the trial, 246 patients who had two to four previous treatments that didn’t work were randomized to receive monthly subcutaneous injections of either 140 mg of Aimovig or placebo for 12 weeks.

Patients on Aimovig also met all secondary endpoints, including reduction in monthly migraine days, decreased migraine-specific drug use per month, a reduction of 75 percent or more in monthly migraine days, and a 100 percent reduction in monthly migraine days. The patients also showed improved physical function and ability to conduct everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID).

"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 Sean Harper,Amgen’s executive vice president of Research and Development, in a statement. "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."

The PDUFA target action date set by the U.S. Food and Drug Administration (FDA) is May 17, 2018. The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for the drug as well.

If approved, Amgen and its partner Novartis will co-commercialize the drug in the U.S. Amgen holds exclusive commercialization rights to it in Japan, and Novartis has exclusive rights to commercialize it in the rest of the world.

Uwe Reuter, trial investigator and managing medical director at Berlin’s Charité Universitätsmedizin, told Reuters. "This is a trial in really difficult to treat patients."

Interestingly, no patients receiving the drug stopped treatment because of side effects. However, about one percent of patients receiving placebo discontinued because of side effects.

GlobalData, an analytics company, projects that CGRP antibodies such as Aimovig, will create combined sales of $4 billion by 2026.

Aimovig blocks the calcitonin gene-related peptide (CGRP) receptor, which is associated with the initiation of migraine. More than 3,000 patients so far have participated in clinical trials of Aimovig.

The World Health Organization (WHO) classifies migraine among the top 10 causes of years lived with disability worldwide. About 8 million Americans suffer migraines with a frequency or severity to impact daily activities.

Amgen and Novartis are ahead in the CGRP market, although there are others closely gaining. These include Eli Lilly’s galcanezumab, Teva Pharmaceuticals’ fremanezumab and Alder BioPharmaceuticals’ eptinezumab. Amgen and Novartis argue that Aimovig differentiates itself from those other drugs because it targets CGRP itself versus targeting the receptor pathway.

PMLive notes, "Lilly’s drug seems to be the closest behind Aimovig, having been filed towards the end of last year…. The drugs are expected to be used most for severe chronic migraine patients who can’t get relief from the current array of therapies, which consists of pain-killing drugs, triptans and repurposed medicines such as the anticonvulsant topiramate or Allergan’s Botox."

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