Japan's Ministry of Health, Labour and Welfare has granted marketing authorization for eptinezumab for the prevention of migraine attacks in adults, H. Lundbeck A/S said. The company said the approval marks an important step for patients in Japan and a first independent launch for Lundbeck Japan, building on 25 years of work in the country.
The drug is a humanized monoclonal antibody designed to bind calcitonin gene-related peptide, or CGRP, and was developed for intravenous administration as a preventive treatment for migraine.
Lundbeck said the Japanese authorization is supported by its global clinical development program, including the Phase III PROMISE-1, PROMISE-2 and DELIVER trials, and the Phase III SUNRISE trial, which assessed efficacy and safety in a predominantly Asian population with chronic migraine. A Phase III long-term extension study, SUNSET, was conducted specifically in Japanese patients to evaluate long-term safety. The company said the safety of eptinezumab has been evaluated in more than 5,000 adults with migraine who received at least one dose, and that the common adverse reactions in placebo-controlled trials were hypersensitivity and infusion-related reactions.
Migraine affects an estimated 8.4% to 11.0% of Japan's population and is the fourth leading cause of years lived with disability in the country, according to the release. Lundbeck said migraine costs the Japanese economy an estimated US$3 billion a year in lost productivity.
Tarek Samad, Lundbeck's executive vice president and head of research and development, said the approval offers adults living with migraine in Japan a new treatment option. The company said eptinezumab was first approved by the U.S. Food and Drug Administration in 2020, followed by approvals including in the European Union and, most recently, South Korea, and that it has been launched in more than 30 markets worldwide.