Japanese pharmaceutical firms, Daiichi Sankyo Company Limited and UCB Japan Co. Ltd have announced that UCB Japan has applied for marketing authorization for lacosamide in Japan as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in patients who have not obtained sufficient response to other antiepileptic drugs.
This application is based on the results of a PIII clinical trial in Japanese and Chinese adult patients with partial-onset seizures which UCB announced in October 2014. The company indicated that at 200 mg or 400 mg per day, lacosamide significantly reduced the incidence of partial-onset seizures compared to placebo.
Adverse events observed in this study were similar to those reported to date in overseas clinical studies and post-marketing surveillance and raised no new concerns about safety. When marketing authorization is obtained, UCB Japan and Daiichi Sankyo will take care of manufacturing and sales/distribution, respectively, in Japan, while the two companies will jointly carry out promotion based on the joint commercialization agreement Daiichi Sankyo and UCB concluded in November 2014.
Daiichi Sankyo and UCB Japan shall contribute to epilepsy patients and healthcare providers in Japan by providing a new option for adjunctive therapy in the treatment of partial-onset seizures.
