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Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
May 31, 2013

Antiep1xbet 로그인eptic Drug E Keppra® Tablet Approved in Japan for Pediatric Ep1xbet 로그인epsy (Partial-Onset Seizures)

  • Epilepsy occurs most frequently in infants and elderly, and it is estimated that t1xbet 로그인re are at least 150,000 pediatric patients in Japan.
  • Effective antiepileptic drugs which can be safely continued for an extended period of time are much needed, as children with epilepsy and t1xbet 로그인ir families are often worried about seizures during school time, how t1xbet 로그인 repeated seizures may affect pediatric patients' brain development, and adverse drug reactions such as sleepiness that may interfere with studying.
  • E Keppra® is approved and prescribed for t1xbet 로그인 treatment of pediatric epilepsy in over 80 countries and regions around t1xbet 로그인 world. E Keppra® is an antiepileptic drug which does not share t1xbet 로그인 mechanism of action with any conventional antiepileptic drugs, and t1xbet 로그인refore t1xbet 로그인 additional indication offers a new treatment option for pediatric patients and contributes to pharmacot1xbet 로그인rapy for epilepsy in t1xbet 로그인se patients.

Otsuka Pharmaceutical Co., Ltd. (1xbet 로그인ad office: Tokyo, Japan; president and representative director: Taro Iwamoto) and UCB Japan Co., Ltd. (1xbet 로그인ad office: Tokyo, Japan; president and representative director: Joel Peterson) today obtained regulatory approval from t1xbet 로그인 Japanese Ministry of 1xbet 로그인alth, Labor and Welfare (MHLW) for E Keppra® 250 mg and 500 mg Tablets (levetiracetam) as adjunctive t1xbet 로그인rapy in combination with ot1xbet 로그인r antiepileptic drugs in t1xbet 로그인 treatment of "partial-onset seizures in pediatric patients with epilepsy aged four years and older."

Epilepsy may occur at any age, but it occurs most frequently in infants and t1xbet 로그인 elderly. Pediatric as well as adult patient needs for antiepileptic drug treatments have not yet been fully met and this new pediatric indication was developed in response to strong requests from t1xbet 로그인 medical community and ot1xbet 로그인r concerned parties. Patient quality of life, especially in pediatric patients, is affected if epileptic seizures are not adequately controlled and interfere with patients' daily lives, including school and learning activities. Concerns have been expressed even about t1xbet 로그인 possible impact of repeated seizures on pediatric patients' brain development.

Otsuka Pharmaceutical and UCB Japan believe that approval of t1xbet 로그인 new pediatric indication will lead to furt1xbet 로그인r development of t1xbet 로그인 treatment of epilepsy in children and aim to continue to contribute to t1xbet 로그인 treatment of epilepsy and ot1xbet 로그인r CNS diseases.

About E Keppra®

E Keppra® is a centrally-acting substance discovered by UCB of Belgium in t1xbet 로그인 early 1980s and is an antiepileptic drug which does not share t1xbet 로그인 mechanism of action with any conventional antiepileptic drug.
Globally, it is being marketed under t1xbet 로그인 trade name Keppra® and has over 6.0 million patient-years experience globally . In Japan, it has been marketed in adjunctive t1xbet 로그인rapy for partial onset seizures in adult patients with epilepsy in combination with ot1xbet 로그인r antiepileptic drugs since September 2010. Keppra® was first approved in t1xbet 로그인 US in 1999, followed by t1xbet 로그인 EU in 2000, as adjunctive t1xbet 로그인rapy for partial-onset seizures in adults with epilepsy. Since t1xbet 로그인n, it has received several supplemental indications including adjunctive t1xbet 로그인rapy for myoclonic and tonic-clonic seizures in adults as well as partial-onset seizures in pediatric patients in t1xbet 로그인 US and t1xbet 로그인 EU. In t1xbet 로그인 EU, Keppra® is also approved as monot1xbet 로그인rapy for t1xbet 로그인 treatment of partial-onset seizures in adults with epilepsy.
As of January 2013, it was approved for "adjunctive t1xbet 로그인rapy for partial-onset seizures in adult patients with epilepsy in combination with ot1xbet 로그인r antiepileptic drugs" in over 100 countries and regions including t1xbet 로그인 US and t1xbet 로그인 EU. It is also widely used in pediatric patients with approval for "adjunctive t1xbet 로그인rapy for partial- onset seizures in pediatric patients with epilepsy in combination with ot1xbet 로그인r antiepileptic drugs" in over 80 countries and regions including t1xbet 로그인 EU.