By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first intravenous treatment for the prevention of migraine in adults, adding to an increasingly crowded field in new migraine drugs.

Lundbeck, a Danish pharmaceutical company, said Vyepti (eptinezumab-jjmr) would be available in April 2020. The recommended dose is 100 mg every 3 months; although some patients may benefit from a dose of 300 mg. Price details were not released.

Vyepti is a humanized monoclonal antibody that prevents migraines by blocking a key protein — calcitonin gene-related peptides (CGRP) -- from binding to nerve receptors in the brain.

Since 2018, the FDA has approved three injectable CGRP inhibitors for migraine prevention and recently approved the first oral tablet for migraine treatment. Vypeti is the first CGRP blocker to be administered intravenously.

“With the approval of Vyepti, I am pleased that we are now able to offer a new IV therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy,” Dr. Deborah Dunsire, President and CEO of Lundbeck, said in a statement.

The efficacy and safety of Vyepti was demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine) involving over 1,700 patients. Treatment benefit was observed for both doses of Vyepti as early as one day after infusion, and there was a sustained reduction of migraines through the second dose.

“The PROMISE-2 data showed that many patients 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.”

Patients were allowed to continue using other migraine or headache medications during the trials. About 2 percent of patients treated with Vyepti discontinued treatment due to adverse reactions, such as an upper respiratory infection and hypersensitivity that causes facial flushing and rash.

Lundbeck has submitted an application for market authorization of Vyepti in Canada and plans to file in the European Union during 2020, followed by the submission of drug applications in other countries around the world, including China and Japan.

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound.