On Feb. 21, 2020, Lundbeck announced that VYEPTI™ (eptinezumab-jjmr) had been approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults and was planned to be available in April 2020. The recommended dose is 100 mg every 3 months; some patients may benefit from a dose of 300 mg. VYEPTI is the first FDA-approved intravenous (IV) treatment for migraine prevention.

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.