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FDA approves Lundbeck’s intravenous preventive treatment for migraine

Deborah Dunsire

Lundbeck has announced that Vyepti (eptinezumab-jjmr) has been approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults and will be available in April 2020.

Vyepti is the first FDA-approved intravenous (IV) treatment for migraine prevention.

“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. The Vyepti clinical program is the first to demonstrate this early benefit,” says Deborah Dunsire, President and CEO of Lundbeck.

Two phase III clinical trials

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). The clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion, and the percentage of patients experiencing a migraine was lower for VYEPTI than with placebo for most of the first 7 days. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of Vyepti. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with Vyepti discontinued treatment due to adverse reactions.

“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.”

Photo of Deborah Dunsire, CEO, Lundbeck