H. Lundbeck A/S (Lundbeck) today announced the acceptance of its new drug application (NDA) for Vyepti® (eptinezumab) by the Ministry of Health, Labor and Welfare (MHLW) in Japan.
The submission reflects the culmination of a series of marketing authorization 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, this will signal the first marketing authorization for Lundbeck in Japan, and the first launch of a biologic by Lundbeck in China and South Korea.
“The acceptance of these regulatory applications signifies a critical milestone in Lundbeck’s Asian development program for eptinezumab.” said Johan Luthman, EVP and Head of Research and Development at Lundbeck. “Eptinezumab has the potential to fulfil a significant unmet need in Asia, where migraine preventive treatments remain underutilized. The eptinezumab global roll-out also paves the way for advancing additional migraine and neuro-rare programs to patients.”
Despite the equally high prevalence of migraine in Asia as compared to Western countries, a significant unmet need remains in terms of appropriate diagnosis, management, and availability of migraine preventive treatments in East Asia.1 In Japan it is reported that of individuals with migraine, 59.4% to 71.8% had never consulted a physician previously and similarly in Korea, this number is estimated to be around 75.6%.1 In China, it is reported that only 13.8% of adults living with migraine will be clinically diagnosed.
The Japanese submission is supported by a robust clinical data package, including results from the SUNRISE Phase 3 registrational trial, which was recently published in Cephalalgia.
In the SUNRISE trial, 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 United States prescribing information and EU Summary of Product Characteristics, with the most common treatment-emergent adverse events being COVID-19 and nasopharyngitis.
Lundbeck is working with regulatory authorities in China, South Korea, and Japan to make eptinezumab available to patients in Asia as quickly as possible. Already approved in more than 30 countries, this step highlights the company’s commitment to improving brain health and addressing the urgent needs of people living with severe migraine.
