Lundbeck Receives Marketing Authorization for Vyepti in Japan

H. Lundbeck A/S has received marketing authorization from Japan's Ministry of Health, Labour and Welfare (MHLW) for Vyepti® (eptinezumab), an intravenous (IV) CGRP-targeted preventive treatment for migraine attacks in adults. This approval marks a significant milestone for patients in Japan and for Lundbeck's continued growth in Asia.

Eptinezumab is the first IV CGRP-targeted preventive treatment approved for migraine in Japan, and it has already been launched in over 30 countries worldwide. The authorization is based on the Phase III SUNRISE trial and the SUNSET long-term extension study, which evaluated the efficacy and safety of eptinezumab in Japanese patients. The approval is part of Lundbeck's 25-year commitment to patients and brain health in Japan, enabling the company to operate independently on the Japanese market.

Migraine is a debilitating neurological disease that affects an estimated 8.4% to 11.0% of the Japanese population, making it the fourth leading cause of years lived with disability. The condition significantly impacts daily functioning, quality of life, work productivity, and social relationships. In Japan, the economic burden of migraine is substantial, with an estimated cost of US$3 billion annually due to lost productivity.

Tarek Samad, Executive Vice President and Head of Research and Development at Lundbeck, stated, "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. Eptinezumab is a differentiated IV CGRP-targeted therapy that offers adults living with migraine an important new treatment option."

Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and was developed for IV administration. The global clinical development program for eptinezumab includes the Phase III PROMISE-1, PROMISE-2, and DELIVER trials, as well as the Phase III SUNRISE trial, which evaluated efficacy and safety in a predominantly Asian population with chronic migraine. The application was further supported by the Phase III SUNSET long-term extension study, which evaluated the long-term safety of eptinezumab in Japanese patients.

In the United States, eptinezumab was first approved by the Food and Drug Administration (FDA) in February 2020 for the preventive treatment of migraine in adults. It was subsequently granted marketing authorization by the European Commission (EC) in January 2022 for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in more than 30 markets worldwide.

H. Lundbeck A/S, a biopharmaceutical company focusing exclusively on brain health, has more than 5,000 employees in over 20 countries and its products are available in more than 80 countries. The company is committed to improving the lives of people with neurological and psychiatric diseases by advancing brain health through innovative research and development programs.