UCB's Vimpat Approved In Japan For Partial Onset Seizures

UCB S.A. UCBJF and partner Daiichi Sankyo Company Limited, announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its anti-epileptic drug, Vimpat, as an adjunctive therapy in the treatment of partial onset seizures, with or without secondary generalization, in adults with epilepsy who have not obtained sufficient response to other anti-epileptic drugs.

The recommended dose starts at 100mg/day, which can be increased to an initial therapeutic dose of 200mg/day at intervals of at least 1 week, each given orally in 2 divided doses.

UCB and Daiichi Sankyo will jointly commercialize Vimpat in Japan. While UCB manufactures and supplies the product, Daiichi Sankyo will manage distribution and book sales.

We note that Vimpat is approved in the U.S., both as an adjunct therapy and monotherapy, for the treatment of partial onset seizures in people with epilepsy who are 17 years and older. The drug is also approved in the EU as an adjunct therapy in the treatment of partial onset seizures with or without secondary generalization in patients aged 16 years and older with epilepsy. A Marketing Authorisation Application for Vimpat, as monotherapy in the treatment of partial onset seizures, is currently under review in the EU.

Meanwhile, Vimpat is being evaluated as an adjunct therapy in two phase III studies – for the treatment of partial onset seizures in pediatrics and for the treatment of primary generalized tonic-clonic seizures. Results from the former study are expected in 2017, while that from the latter study are expected in 2019.

According to information provided by the company, epilepsy affects approximately 65 million people worldwide. Approximately 1 in every 26 people is expected to suffer from epilepsy in their lifetime. In Japan, approximately 1 million individuals are estimated to be affected by the disease.

Drugs currently approved to treat epilepsy include Novartis AG’s (NYSE:NVS) Tegretol, AbbVie Inc.’s (NYSE:ABBV) Depakote and Johnson & Johnson’s (NYSE:JNJ) Topamax.

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