Danish biopharmaceutical company H. Lundbeck A/S (CPH:HLUN-A) announced on Tuesday that the Ministry of Food and Drug Safety (MFDS) of South Korea has granted marketing authorisation for eptinezumab for use in adults with migraine.

Affecting one in seven people, migraine is a progressive and debilitating neurological disease characterised by recurrent attacks of severe headache often accompanied by nausea, vomiting, and sensitivity to light and sound.

Eptinezumab is a humanised monoclonal antibody that binds to calcitonin gene-related peptide (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 randomised, placebo-controlled trial conducted in a predominantly Asian population with chronic migraine.

Eptinezumab was first approved by the US Food and Drug Administration (FDA) 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.