Daiichi Sankyo Company, Limited and UCB Japan Co., Ltd have announced that they have launched Vimpat tablets 50 mg and 100 mg (generic name: lacosamide; date of approval: July 4, 2016; date of listing in the NHI reimbursement price list in Japan: August 31, 2016).
Vimpat 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.
Vimpat has been approved over 70 countries since it was first approved in August 2008 in Europe, followed by the USA in October of the same year.
Daiichi Sankyo and UCB partner to commercialize Vimpat in Japan, as agreed previously by both companies in November 2014. UCB manufactures and supplies the product; Daiichi Sankyo manages distribution and book sales in Japan, with both companies promoting Vimpat in Japan.
Daiichi Sankyo and UCB are confident that Vimpat will contribute to patients and healthcare providers in Japan by offering a new treatment option in adjuvant therapy for partial-onset seizures in epilepsy patients.
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. Seizures associated with epilepsy are classified into three major groups based on their clinical symptoms: partial-onset seizures (which may sometimes progress to secondary generalized seizures), generalized seizures, and unclassified seizures. Partial-onset seizures show the highest incidence among these three types accounting for approximately 60% of the total.