Daiichi Sankyo Company Limited and UCB Japan Co Ltd announced that they have filed an application for partial amendment of approval to use lacosamide (Vimpatò tablets 50 mg and 100 mg) in monotherapy for partial-onset seizure (including secondary generalized seizures) in patients with epilepsy.
This application is based on the results of phase 3 international clinical trial in 888 adult patients (aged 16 and over), including Japanese patients with newly or recently diagnosed epilepsy. Monotherapy with lacosamide showed non-inferiority to monotherapy using controlled-release carbamazepine formulation in terms of the primary efficacy endpoint. The adverse event (AE) profile was comparable to that observed in previous lacosamide trials, including dizziness, headache, fatigue, somnolence and nausea.
Daiichi Sankyo and UCB expect lacosamide to be able to contribute to patients and healthcare providers by offering a new treatment option.
Lacosamide is a novel antiepileptic drug with a new mechanism of action which differs from that of existing antiepileptic drugs. Specifically, it suppresses excessive excitation of neurons by selectively promoting gradual inactivation of potential-dependent Na channels. Its usefulness was demonstrated in a Japan-China collaborative phase 3 clinical trial in adult patients (aged 16 and over) with partial-onset seizures including Japanese patients and a long-term extended trial. Based on results of these clinical trials, lacosamide was approved in Japan for “adjuvant therapy for partial-onset seizures in patients with epilepsy” in July 2016. In Japan, Daiichi Sankyo and UCB will partner to commercialize lacosamide in Japan, as agreed previously by both companies in November 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. Lacosamide was approved for “monotherapy for partial-onset seizures in patients with epilepsy” in the USA in August 2014.
Epilepsy affects approximately 65 million people around the world with a prevalence of about 1%. It may occur over a wide age range from infants to senior citizens and its incidence does not vary much across countries, geographies, genders or races. The number of patients with epilepsy is estimated to total about one million in Japan with approximately 57,000 patients every year. Epilepsy is a disease with unmet medical needs even today with a great majority of patients needing long-term pharmacotherapy and over 30% of patients being reportedly unable to adequately control seizures despite treatment with existing antiepileptic drugs.
UCB has a rich heritage in epilepsy with more than 20 years of experience in the research and development of anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients and driven by science in our commitment to support patients with 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.
UCB, based in Brussels, Belgium 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 including those of the central nervous system or the immune system.