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  5. E Keppra® 500 mg Injectable For Monotherapy Treatment of Epilepsy Submitted For Regulatory Review in Japan

August 4, 2014

Otsuka Pharmaceutical Co., Ltd.
UCB Japan Co., Ltd.

Pharmaceuticals

E Keppra® 500 mg Injectable For Monotherapy Treatment of Epilepsy Submitted For Regulatory Review in Japan

  • E Keppra® IV Drip Infusion received marketing authorization in Japan last month as an adjunctive therapy for partial-onset seizure in epilepsy patients. An application for use as monotherapy has now also been submitted.
  • Since approximately 70% of patients can live seizure-free lives if they are able to continuously take anti-epileptic drugs, development of injectable formulations that can be administered to patients who have difficulty swallowing oral drugs has been desired.
  • Launched in Japan in 2010, E Keppra® has already been used in approximately 100,000 patients and attained the top market share for anti-epileptics in Japan.*1 It has been approved for use in more than 100 countries and regions and is prescribed to a wide range of patients from children to the elderly. Injectable formulations were first approved in Europe and the US in 2006 and have been approved in over 40 countries and regions.

Otsuka Pharmaceutical Co., Ltd. (headquarters: Tokyo; President and Representative Director: Taro Iwamoto;) and UCB Japan Co., Ltd. (headquarters: Tokyo; President and Representative Director: Joel Peterson) filed an application for partial changes in marketing authorization of E Keppra® for IV Drip Infusion 500 mg (levetiracetam) in Japan in order to add an indication of monotherapy for partial-onset seizures (including secondary generalized seizures) in epilepsy patients.

  • *1 ©IMS Health, JPM, April-June 2014. Prior permission required for use.

Information in this news release was current as of the original release date.

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