• Approval granted by Japan's Ministry of Health, Labour and Welfare (MHLW)
• Eptinezumab is the only intravenous (IV) CGRP-targeted preventive treatment approved for the prevention of migraine attacks in adults and launched in over 30 countries worldwide
• Authorization supported by the Phase III SUNRISE trial and the SUNSET long-term extension study in Japanese patients
• Building on 25 years of commitment to patients and brain health in Japan, the approval paves the way for Lundbeck's first launch in Japan as Marketing Authorization holder, enabling Lundbeck to operate independently on the Japanese market

H. Lundbeck A/S (Lundbeck)  announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has granted marketing authorization for eptinezumab for the prevention of migraine attacks in adults, marking an important milestone for patients in Japan and for Lundbeck's continued growth in Asia.

Migraine is a debilitating neurological disease characterized by recurrent attacks of severe headache often accompanied by nausea, vomiting, and sensitivity to light and sound. In Japan, migraine affects an estimated 8.4%–11.0% of the population¹ and is the fourth leading cause of years lived with disability.² Beyond the physical symptoms, migraine significantly affects daily functioning, quality of life, work productivity and life course.² Migraine is estimated to cost the Japanese economy US$ 3 billion every year in lost productivity.³

"This approval represents a significant advancement for people living with migraine 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."

Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and was developed for IV administration as a preventive treatment for migraine.

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.⁴ 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.²

Eptinezumab was first approved by the U.S. Food and Drug Administration in 2020 for the preventive treatment of migraine in adults, followed by additional approvals including in the European Union and most recently South Korea. It has since been launched in more than 30 markets worldwide.