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NEWS 2026
February 24, 2026
Pharmaceuticals
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Transfer of Marketing Authorization for Epileptic Seizures treatment FINTEPLA® Oral Solution 2.2 mg/mL
Kyoto, Japan, February 24, 2026 - Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; Head Office: Kyoto; President: Toru Nakai) announces that the marketing authorization in Japan for FINTEPLA® Oral Solution 2.2 mg/mL (generic name: fenfluramine hydrochloride) will be transferred from UCB Japan Co., Ltd. (UCB Japan; Head Office: Tokyo; President & Representative Director: Kanako Kikuchi) to Nippon Shinyaku effective April 1, 2026.
In Japan, UCB Japan obtained approval for the drug in September 2022 as a treatment for epileptic seizures associated with Dravet syndrome, and in March 2024 for an additional indication for epileptic seizures associated with Lennox-Gastaut syndrome. Until now, UCB Japan has been responsible for manufacturing and marketing, while Nippon Shinyaku has handled sales in Japan.
With this transfer of marketing authorization, Nippon Shinyaku will become the marketing authorization holder for the drug and will continue to provide information and collect data to promote its proper use.
About Nippon Shinyaku
Based on Nippon Shinyaku’s business philosophy, “Helping people lead healthier, happier lives,” we aim to be an organization trusted by the community through creating unique medicines that will bring hope to patients and families suffering from illness. Please visit our website (https://www.nippon-shinyaku.co.jp/english/) for products or detailed information.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of € 6.15 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB).
UCB Japan Co., Ltd. was established in 1988 as the Japanese subsidiary of UCB, and is focused on treatment in key areas such as epilepsy, rheumatoid arthritis, and psoriasis. In 2023, we expanded our portfolio to include treatments for rare diseases. As a biopharma leader committed to creating value for patients, our goal is to offer new solutions for those who have not achieved sufficient improvement with existing treatment.
For more information about UCB Japan, please visit https://www.ucbjapan.com
Contact
Corporate Communications Dept., Nippon Shinyaku
e_mail_kouhou@po.nippon-shinyaku.co.jp