Daiichi Sankyo Company, Limited and UCB Biopharma SPRL (UCB) announced the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for lacosamide (brand name Vimpat) as an adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adult patients with epilepsy who have not obtained sufficient response to other antiepileptic drugs.
"Today’s announcement reinforces our commitment to improving the lives of people living with epilepsy around the world and to increasing patient access to our core medicines”, explained Jean-Christophe Tellier, CEO, UCB. “This is an example of our collaborative, patient-led and science-driven approach delivering benefits by providing additional treatment options for people living with epilepsy. We look forward to successfully launching lacosamide in Japan and continuing our partnership with Daiichi Sankyo.”
"Daiichi Sankyo is very excited to work with long-time valued partner, UCB, to further contribute to the management of epilepsy in Japan by adding lacosamide as a new therapeutic option to our existing Central Nervous System (CNS) portfolio”, explained Joji Nakayama, representative director, president and CEO, Daiichi Sankyo. “Lacosamide’s well-established efficacy and tolerability profile will provide doctors in Japan and their patients with an additional treatment option to help manage their condition. We very much look forward to realizing this opportunity.”
DaiichiSankyo and UCB will partner to commercialize lacosamide in Japan, as agreed previously by both companies in 2014. UCB will manufacture and supply the product; Daiichi Sankyo will manage distribution and book sales in Japan, with both companies promoting lacosamide in Japan.
Epilepsy is a disease of the brain affecting approximately 65 million people worldwide. It is thought to affect approximately 1 million people in Japan. 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%) after two unprovoked seizures or diagnosis of an 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.
Vimpat (film-coated tablets) is approved in Japan for: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in patients with epilepsy who have not obtained sufficient response to other antiepileptic drugs; Dosage and administration: For adults, the recommended starting dose of lacosamide is 100mg/day, which should be increased to an initial therapeutic dose of 200mg/day at intervals of at least 1 week, each given orally in 2 divided doeses. However, depending on response and tolerability, the maintenace doese can be further increased to maximum recommended daily dose of 400mg, and dose increaments should be made within doeses of 100mg/day at intervals of at least 1 week.