FDA Approves Eptinezumab--the Only Infusion Treatment for Migraine Prevention

The Food and Drug Administration has granted approval for eptinezumab-jjmr (Vyepti; Lundbeck, Deerfield, IL) for the preventive treatment of migraine (episodic or chronic). Eptinezumab is the first intravenous monoclonal antibody inhibitor of calcitonin gene-related peptide (CGRP) approved by the FDA, and the fourth drug in this class (CGRP inhibitors) to be approved. 

Eptinezumab will be available in April 2020. The recommended dose is 100 mg every 3 months; some individuals may benefit from a higher dose of 300 mg every 3 months. 

“The data showed that many patients with chronic migraine can achieve reduction in migraine days of at least 75 percent and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Dr. Peter Goadsby, a professor of neurology at King’s College, London and the University of California, San Francisco. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”

Approval was based upon data from the PROMISE-1 (NCT02559895) clinical trial of eptinezumab for episodic migraine and the PROMISE-2 (NCT02974153) clinical trial of eptinezumab for chronic migraine (Table). Treatment benefit was observed for both doses of eptinezumab as early as day 1 after infusion and treatment benefits were sustained over a 6-month period with 2 quarterly doses. 

In months 1 through 3, 56.3% and 49.8% of those with episodic migraine who were treated with 300 mg or 100 mg of eptinezumab respectively achieved at least a 50% reduction in migraine days per month (MMD) vs 37.4% of those treated with placebo (nominal P=.009). For those with chronic migraine treated with 300 mg or 100 mg of eptinezumab 300 or 100 mg, 61.4% (P<.001) and 57.6% (P<.001) vs 39.3% of those who received placebo had at least a 50% reduction in MMD.

Dr. Deborah Dunsire, president and chief executive officer of Lundbeck, commented “With the approval of Vyepti, I am pleased that we are now able to offer a new intravenous therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy. The Vyepti clinical program is the first to demonstrate this early benefit.”

Participants in the trial who received at least 1 dose of eptinezumab had a low rate of adverse events, which most commonly were nasopharyngitis and hypersensitivity. Only 1.9% of enrolled participants discontinued treatment because of adverse events.