H. Lundbeck A/S (Lundbeck) announced that the European Medicines Agency?s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended granting a marketing authorization to Vyepti? (eptinezumab) in the European Union (EU) for the preventive treatment of migraine in adults who have at least 4 migraine days per month. Subject to final approval by the European Commission, Vyepti will be the first and only approved IV treatment for migraine prevention in EU. CHMP based its positive opinion on the efficacy and safety of Vyepti, which has been demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine). The clinical trial program demonstrated a reduction in monthly migraine days over placebo which was observed for both doses of Vyepti as early as day 1 post-infusion, and a sustained effect on patientrelevant outcomes was observed for up to 96 weeks. The safety of Vyepti was evaluated in approximately 2,000 patients with migraine who received at least one dose of Vyepti. The most common adverse reactions (=2% and at least 2% 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% of patients treated with Vyepti discontinued treatment due to adverse reactions. Vyepti? (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020 and it is launched on the U.S. market. In addition, Vyepti has been approved in Australia, Canada, Kuwait, Singapore and U.A.E and, is currently under review in 10 markets around the world.