02 March 2020 | News
Anti-epilepsy Drug VIMPAT ®, Submission for Supplemental Application for Approval in Japan
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UCB Japan Co., Ltd, and Daiichi Sankyo Company, Limited are pleased to announce that a supplemental application for VIMPAT® (generic name: lacosamide) was filed in Japan to expand the indication for adjunctive therapy for tonic-clonic seizures in epilepsy patients as a partial change in approved items of the manufacturing and marketing approval.
This application is based on the results of a multinational PIII clinical trial in 242 adult and pediatric epilepsy patients aged 4 years and older (including Japanese patients) with tonic-clonic seizures showing inadequate control under treatment with existing anti-epileptic drugs. The study met its primary endpoint (the time to the second tonic-clonic seizure during the 24-week evaluation period, i.e., the risk of developing the second tonic-clonic seizure) showing statistically significant difference between patients groups administered with lacosamide vs placebo. No new concerns about safety were raised.
UCB and Daiichi Sankyo expect that they can contribute to patients by offering a new treatment option for epilepsy with this drug.