Daiichi Sankyo Company Limited and UCB Japan Company Ltd, a division of UCB group, 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 20141. 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 authorisation is obtained, UCB Japan Company Ltd. (UCB Japan) and Daiichi Sankyo will take care of manufacturing and distribution respectively in Japan while the two companies will jointly carry out promotion based on the joint commercialisation agreement Daiichi Sankyo and UCB concluded in November 2014.
Daiichi Sankyo and UCB Japan will contribute to epilepsy patients and healthcare providers in Japan by providing a new option for adjunctive therapy in the treatment of partial-onset seizures.
Epilepsy is a disease of the brain that affects approximately 65 million people worldwide. It is defined as either the occurrence of two or more unprovoked seizures >24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60 per cent) after the occurrence of two unprovoked seizures or diagnosis of epilepsy syndrome. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age, and approximately 1 in 26 people will develop epilepsy in their lifetime.
Lacosamide was first launched in the European Union in September 2008 under the brand name Vimpat as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. At present, lacosamide is available in 46 countries worldwide. In the US and Europe, it is available as film-coated tablets, syrup and solution for i.v. infusion. Lacosamide solution for i.v. infusion is an alternative when oral administration becomes temporarily not feasible. UCB holds the world-wide rights for development, manufacturing and marketing of lacosamide. It is currently not approved in Japan for the treatment of epilepsy.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets.
Established in 1988, UCB Japan markets a number of products including the allergic disease treatment Zyrtec tablets (cetirizine).