Trial Shows Antibody Reduces Days with Migraines

(R. Nial Bradshaw, Flickr)

17 November 2016. First results from a late-stage clinical trial shows a synthetic antibody reduces the number of days with migraines per month among people with episodic or infrequent migraines. The synthetic antibody, called erenumab, is jointly developed by the pharmaceutical companies Amgen and Novartis that reported the results today.

Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. The web site Migraine.com estimates 37 million people in the U.S. suffer from migraines, and cites World Health Organization data indicating migraines affect 18 percent of American women and 7 percent of men.

Migraines experienced 14 days a month or fewer are called episodic migraines, while chronic migraines are experienced 15 days a month or more. A study published 2013, however, suggests that individuals with episodic migraines, about 90 percent of those with migraines, who do not get adequate treatment are 3 times more likely to progress to chronic migraines.

Erenumab is designed to prevent migraines by limiting receptors for calcitonin gene-related peptide. This peptide and its receptors are expressed in a number of different cells throughout the central and peripheral nervous systems, and regulate inflammation and pain arising from the stimulation of nerve cells. Erenumab acts by inhibiting the peptide’s receptors, not the peptide itself, and is administered monthly by injections under the skin.

The clinical trial enrolled 955 participants with a history of episodic migraine at 129 sites in North America and Europe. Participants were randomly assigned to receive injections of erenumab, at doses of 70 or 140 milligrams, or a placebo once a month for 6 months. Study teams looked primarily at the average number of days per month participants experienced migraines, compared to a baseline measure taken before the injections.

The results show individuals receiving erenumab experienced fewer days per month with migraines compared to those receiving the placebo. Before the trial, participants average 8.3 days per month with migraines. Individuals receiving erenumab reported 3.2 and 3.7 fewer days per month of migraines, for injections of 70 and 140 milligrams respectively. Placebo recipients, however, experienced 1.8 fewer migraine days per month, a large enough difference from erenumab recipients to be statistically reliable.

Occurrences of adverse effects, say the companies, were similar for participants receiving erenumab or the placebo: common cold symptoms, inflamed sinuses, and upper respiratory tract infections. The adverse effects in this trial were much like those reported in other intermediate and late-stage trials of erenumab.

“The results of this study are important,” says Amgen vice-president Sean Harper in a company statement, “because they confirm the results from our previous studies and add to our body of research in episodic migraine. We look forward to working with regulatory authorities to pursue approval of erenumab and making this novel migraine prevention treatment available to patients and physicians.”

Amgen originally developed erenumab, but in August 2015 joined forces with Novartis to co-develop treatments for neurological disorders, including erenumab, as well as therapies for Alzheimer’s disease. Under their agreement, Amgen retains commercialization rights in the U.S., Canada and Japan for migraine drugs, and Novartis has commercialization rights in Europe and rest of world.

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