Daiichi and UCB file for new indication for lacosamide in Japan

Japanese drug major Daiichi Sankyo (TSE 4568) and the Japanese subsidiary if Belgium’s UCB (Euronext Brussels: UCB) have filed an application for partial amendment of approval to use lacosamide (brand name: Vimpat) tablets 50mg and 100mg) in monotherapy for partial-onset seizure (including secondary generalized seizures) in patients with epilepsy.

This application is based on the results of Phase III 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.