Japan's MHLW Approves Lundbeck's Vyepti (eptinezumab), the Only IV CGRP-Targeted Migraine Preventive in the Country
核心洞察
Japan's Ministry of Health, Labour and Welfare granted marketing authorization to eptinezumab for the prevention of migraine (搜索) attacks in adults, Lundbeck announced on Sept. 16, 2026.
Eptinezumab is the only intravenous CGRP-targeted preventive migraine (搜索) treatment approved in Japan and is now launched in more than 30 markets worldwide.
The authorization was supported by the Phase III SUNRISE trial in a predominantly Asian chronic migraine (搜索) population and the SUNSET long-term extension study in Japanese patients.
H. Lundbeck A/S announced on Sept. 16, 2026, that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorization for eptinezumab for the prevention of migraine (搜索) attacks in adults. The decision makes eptinezumab the only intravenous (IV) CGRP-targeted preventive treatment approved for the prevention of migraine attacks in adults in Japan, and it has now been launched in more than 30 countries worldwide.
The approval also marks a commercial milestone for Lundbeck: it paves the way for the company's first launch in Japan as marketing authorization holder, enabling Lundbeck to operate independently on the Japanese market after 25 years of commitment to patients and brain health in the country.
"This approval represents a significant advancement for people living with migraine (搜索) in Japan, where the disease continues to place a substantial burden on patients, families, and society," said Tarek Samad, EVP and Head of Research and Development at Lundbeck. "Eptinezumab is a differentiated IV CGRP-targeted therapy that offers adults living with migraine an important new treatment option, and we are proud to bring this innovative medicine to patients in Japan. This approval also marks an exciting new chapter for Lundbeck Japan as we prepare for our first independent launch, building on 25 years of commitment to patients and brain health in the country."
Mechanism and Administration
Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a key molecule involved in migraine (搜索) pathways, and was developed for IV administration as a preventive treatment for migraine. Its efficacy and safety were evaluated in two Phase III clinical trials: PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine (搜索). In both trials, eptinezumab met its primary endpoint of decrease in monthly migraine days (MMDs) over weeks 1–12.
The safety of eptinezumab has been evaluated in more than 5,000 adult patients with migraine (搜索) who received at least one dose. Common adverse reactions in the placebo-controlled clinical trials for the preventive treatment of migraine were hypersensitivity and infusion-related reactions.
Evidence Base in Asian and Japanese Populations
The Japanese marketing authorization is supported by the global clinical development program for eptinezumab, including the Phase III PROMISE-1, PROMISE-2 and DELIVER trials, together with data from the Phase III SUNRISE trial, which evaluated efficacy and safety in a predominantly Asian population with chronic migraine (搜索). The application was further supported by the Phase III SUNSET long-term extension study conducted specifically in Japanese patients to evaluate the long-term safety of eptinezumab.
Regulatory History
Eptinezumab was first approved by the U.S. Food and Drug Administration (搜索) in February 2020 for the preventive treatment of migraine (搜索) in adults. In January 2022, the European Commission granted marketing authorization for the prophylaxis of migraine in adults who have at least four migraine days per month. Additional approvals followed, most recently in South Korea. In Japan, eptinezumab is approved for the prevention of migraine attacks in adults.
Disease Burden in Japan
Migraine (搜索) is a complex and disabling neurological disease characterized by recurrent attacks of severe headache typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound. In Japan, migraine affects an estimated 8.4%–11.0% of the population and is the fourth leading cause of years lived with disability. Beyond the physical symptoms, migraine significantly affects daily functioning, quality of life, work productivity and life course, and is estimated to cost the Japanese economy US$3 billion every year in lost productivity.
Migraine (搜索) is one of the most prevalent neurological diseases worldwide and remains a leading cause of disability, particularly among people under the age of 50. As migraine frequency and severity increase, attacks may become harder to control, contributing to greater disease burden and, without appropriate preventive management, progression to chronic migraine (搜索).
Lundbeck is a biopharmaceutical company focusing exclusively on brain health, with more than 70 years of experience in neuroscience. The company has more than 5,000 employees in more than 20 countries, and its products are available in more than 80 countries.