Valby, Denmark – – September 18, 2026 -- H. Lundbeck A/S has secured marketing authorization from Japan's Ministry of Health, Labour and Welfare for eptinezumab, branded Vyepti, as a preventive treatment for migraine attacks in adults, opening the company's first independent product launch in the country.
MHLW clears the only IV CGRP-targeted migraine preventive on the market
Eptinezumab remains the sole intravenous CGRP-targeted therapy approved for migraine prevention, now available in more than 30 markets worldwide following the Japanese clearance. The drug was first approved by the U.S. FDA in February 2020, followed by the European Commission in January 2022 and, most recently, South Korea.
Migraine costs Japan's economy an estimated $3 billion annually in lost productivity
Migraine affects an estimated 8.4%–11.0% of Japan's population and ranks as the fourth leading cause of years lived with disability in the country. The disease imposes a US$3 billion annual productivity loss on the Japanese economy, according to figures cited by Lundbeck.
Approval rests on Phase III SUNRISE trial and Japan-specific SUNSET extension study
The Japanese authorization builds on the global Phase III program for eptinezumab, including the PROMISE-1, PROMISE-2 and DELIVER trials, combined with data from the Phase III SUNRISE trial conducted in a predominantly Asian population with chronic migraine. The Phase III SUNSET long-term extension study, run specifically among Japanese patients, supported the drug's long-term safety profile.
Lundbeck to operate independently in Japan after 25 years in the market
The clearance marks Lundbeck's first launch in Japan as marketing authorization holder, allowing the company to operate independently rather than through a partner, following 25 years of activity in the country's brain-health sector. Tarek Samad, EVP and Head of Research and Development at Lundbeck, called the approval a new chapter for Lundbeck Japan as the company prepares its standalone commercial rollout.
Safety data span more than 5,000 adult patients across clinical trials
Eptinezumab's safety profile has been evaluated in over 5,000 adult migraine patients who received at least one dose across placebo-controlled trials, with hypersensitivity and infusion-related reactions reported as the most common adverse events. In the pivotal PROMISE-1 and PROMISE-2 trials, the drug met its primary endpoint of reducing monthly migraine days over weeks 1-12 in both episodic and chronic migraine populations.