Danish biopharmaceutical company H. Lundbeck A/S (CPH: HLUN-B) said on Wednesday it has received marketing authorisation from Japan's Ministry of Health, Labour and Welfare for eptinezumab for the prevention of migraine attacks in adults.

Lundbeck said eptinezumab is the only intravenous CGRP-targeted preventive migraine therapy approved in Japan. The therapy was first approved in the United States in 2020, followed by authorisations in the European Union and South Korea, and it has now been launched in over 30 countries worldwide.

The Japanese decision is supported by Lundbeck's global clinical programme, including the Phase III PROMISE-1, PROMISE-2 and DELIVER trials, as well as the SUNRISE study in predominantly Asian patients with chronic migraine. Additional long-term safety data came from the SUNSET extension study conducted in Japanese patients.

Migraine affects an estimated 8.4%-11.0% of the Japanese population and is the fourth leading cause of years lived with disability, with annual productivity losses estimated at USD3bn.

Eptinezumab is a humanised monoclonal antibody that binds to calcitonin gene-related peptide and is administered intravenously as a preventive treatment. Its efficacy and safety have been evaluated in more than 5,000 adults, with common adverse reactions including hypersensitivity and infusion-related events.