• Approval granted by South Korea's Ministry of Food and Drug Safety (MFDS)
• Eptinezumab is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the preventive treatment of migraine in adults
• Authorization supported by the Phase 3 SUNRISE trial conducted in a predominantly Asian population with chronic migraine
• Provides a new preventive treatment option for people living with migraine in Korea

H. Lundbeck A/S  announced that the Ministry of Food and Drug Safety (MFDS) of South Korea has granted marketing authorization for eptinezumab for use in adults with migraine.

Migraine is a progressive and debilitating neurological disease characterized by recurrent attacks of severe headache often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine affects one in seven people and is a leading cause of disability worldwide.¹

Approximately 11% of the population in Korea currently lives with migraine, a figure that may be underestimated.^1,2 Despite its high prevalence, preventive treatments are often underutilized.³ Significant gaps remain in diagnosis, access to care, and effective treatment options.

"This approval marks an important milestone for people living with migraine in Korea, many of whom remain underserved by existing preventive options," said Johan Luthman, EVP and Head of Research and Development at Lundbeck. "Expanding access to eptinezumab reflects our commitment to advancing brain health and delivering innovative therapies to patients across Asia who continue to experience a significant disease burden."

Eptinezumab is a humanized monoclonal antibody that binds to CGRP and was intentionally designed for intravenous (IV) administration. The decision is based on results from the confirmatory Phase 3 trials PROMISE-1, PROMISE-2, DELIVER and SUNRISE. The latter trial, SUNRISE, was a randomized, placebo-controlled trial conducted in a predominantly Asian population with chronic migraine.

Eptinezumab was first approved by the U.S. Food and Drug Administration for the preventive treatment of migraine in adults, followed by additional approvals including in the European Union. It has since been launched in more than 30 markets worldwide.