Danish pharmaceutical company H. Lundbeck A/S (CPH:HLUN-A) announced on Friday that Japan's Ministry of Health, Labor and Welfare (MHLW) has accepted its new drug application (NDA) for Vyepti (eptinezumab), a preventive migraine treatment.

This submission reflects the culmination of a series of marketing authorisation applications across Asia, including China and South Korea, with the goal of enabling access to eptinezumab for patients living with migraine who are eligible for preventive therapy. If granted, it will be the first marketing authorisation for Lundbeck in Japan and the first launch of a biologic by Lundbeck in China and South Korea.

The Japanese submission is supported by clinical data including results from the SUNRISE Phase 3 registrational trial, in which eptinezumab was shown to be efficacious in the preventive treatment of migraine. The safety profile of eptinezumab was generally similar to placebo, previous trials, and to the current labelled safety information in the US prescribing information and EU Summary of Product Characteristics, with the most common treatment-emergent adverse events being COVID-19 and nasopharyngitis.

Lundbeck said that it is working with regulatory authorities in China, South Korea, and Japan to make eptinezumab available to patients in Asia as quickly as possible.