The approval, supported by the Phase III SUNRISE and SUNSET trials, brings a specialized preventive option to a country where migraines impact up to 11% of the population. Beyond the physical toll of the disease, the condition is estimated to cost the Japanese economy approximately $3 billion annually in lost workforce productivity, ranking it as a leading cause of disability.
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Lundbeck secures Japanese approval for migraine drug Vyepti
Japan’s Ministry of Health, Labour and Welfare has authorized the use of Vyepti, an intravenous CGRP-targeted treatment, for the prevention of adult migraines. This regulatory milestone marks a significant expansion for the Danish pharmaceutical company, signaling its first independent product launch within the Japanese market.
For Lundbeck, the authorization is a key strategic shift. Having maintained a presence in Japan for 25 years, the company will now operate as an independent marketing authorization holder for the first time. The drug, a humanized monoclonal antibody designed to block the calcitonin gene-related peptide, is already available in over 30 countries. Following its initial U.S. clearance in 2020, Vyepti joins a growing global portfolio aimed at addressing complex neurological disorders.
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