Valby, Denmark, September 16, 2026
H. Lundbeck A/S announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorization for Vyepti® (eptinezumab) for the prevention of migraine attacks in adults. The regulatory decision expands availability of Lundbeck’s intravenous (IV) migraine preventive therapy into Japan and represents a significant development in the company’s neuroscience portfolio. The authorization is supported by clinical evidence from the Phase III SUNRISE trial and the SUNSET long-term extension study, which evaluated eptinezumab in Japanese patients. Lundbeck said the authorization also establishes a pathway for its first independent product launch in Japan as a Marketing Authorization Holder, building on its long-standing presence and focus on brain health in the country.
Vyepti Targets CGRP for Migraine Prevention
Eptinezumab is a humanized monoclonal antibody designed to target calcitonin gene-related peptide (CGRP), a signaling molecule involved in migraine biology. Unlike oral preventive medicines, Vyepti is administered through intravenous infusion, providing a different administration option for adults requiring preventive migraine treatment. The Japanese authorization follows a broader global clinical development program that includes the Phase III PROMISE-1, PROMISE-2 and DELIVER trials, alongside the SUNRISE study conducted in a predominantly Asian population with chronic migraine. In the pivotal clinical development program, eptinezumab demonstrated reductions in monthly migraine days, an important measure used to assess preventive treatment effectiveness. The medicine has previously received regulatory approvals in multiple markets, including the United States and European Union, and has been launched in more than 30 markets worldwide.
Japanese Studies Support Regulatory Authorization
The Japanese regulatory submission was supported by data specifically addressing patients in Japan. The Phase III SUNRISE trial evaluated the efficacy and safety of eptinezumab in adults with chronic migraine, while the SUNSET long-term extension study generated additional information on the long-term safety of treatment in Japanese patients. SUNRISE was a randomized, placebo-controlled Phase III study involving 983 adult participants, with participants receiving eptinezumab at 100 mg, eptinezumab at 300 mg, or placebo. The primary endpoint evaluated the change from baseline in monthly migraine days during Weeks 1–12, while additional endpoints assessed migraine responder rates and other measures of treatment response. These clinical data formed part of the evidence supporting regulatory submissions across Asian markets.
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New Treatment Option for Adults With Migraine
Migraine is a neurological disease characterized by recurrent attacks of moderate to severe headache, often accompanied by nausea, vomiting, and sensitivity to light or sound. Lundbeck estimates that migraine affects approximately 8.4% to 11.0% of the population in Japan, highlighting the substantial health and societal burden associated with the condition. The company also notes that migraine can affect daily functioning, quality of life and workplace productivity. In Japan, Lundbeck estimates that lost productivity associated with migraine contributes approximately US$3 billion in annual economic costs. The Japanese authorization adds another regulatory milestone for Vyepti, which was first approved by the U.S. Food and Drug Administration in 2020 for preventive treatment of migraine in adults. The treatment subsequently received European authorization and approvals in other international markets. With the Japanese decision, Lundbeck is preparing to expand its commercial presence in the country through an independent launch. The company said the milestone builds on approximately 25 years of commitment to patients and brain health in Japan and supports its broader strategy of developing and providing treatments for neurological diseases.
Source: Lundbeck press release
