US regulators have approved Teva’s Ajovy for the preventative treatment of migraine in adults.

Ajovy (fremanezumab) is a monoclonal antibody designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP), which is believed to play a role in both migraine and cluster headache.

The drug is the first and only anti-CGRP treatment approved for the prevention of migraine with quarterly and monthly dosing options.

In one clinical trial, the percentage of chronic migraine patients with a reduction of at least 50% in the average number of headache days per month was 38% in the fremanezumab-quarterly group, 41% in the fremanezumab-monthly group, and 18 percent in the placebo group.

The reduction in the average number of headache days per month was around 4.3 with fremanezumab quarterly, 4.6 with monthly dosing, and 2.5 with placebo.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” said Stephen Silberstein, MD, director, Jefferson Headache Center at Thomas Jefferson University Hospital, and lead investigator of the Phase III clinical trial programme for AJOVY.

“About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”