May 31, 2013
Otsuka Pharmaceutical Co., Ltd.
Antiepileptic Drug E Keppra® Tablet Approved in Japan for Pediatric Epilepsy (Partial-Onset Seizures)
- Epilepsy occurs most frequently in infants and elderly, and it is estimated that there 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 their families are often worried about seizures during school time, how the 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 the treatment of pediatric epilepsy in over 80 countries and regions around the world. E Keppra® is an antiepileptic drug which does not share the mechanism of action with any conventional antiepileptic drugs, and therefore the additional indication offers a new treatment option for pediatric patients and contributes to pharmacotherapy for epilepsy in these patients.
Otsuka Pharmaceutical Co., Ltd. (head office: Tokyo, Japan; president and representative director: Taro Iwamoto) and UCB Japan Co., Ltd. (head office: Tokyo, Japan; president and representative director: Joel Peterson) today obtained regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for E Keppra® 250 mg and 500 mg Tablets (levetiracetam) as adjunctive therapy in combination with other antiepileptic drugs in the 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 the 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 the medical community and other 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 the possible impact of repeated seizures on pediatric patients' brain development.
Otsuka Pharmaceutical and UCB Japan believe that approval of the new pediatric indication will lead to further development of the treatment of epilepsy in children and aim to continue to contribute to the treatment of epilepsy and other CNS diseases.
About E Keppra®
E Keppra® is a centrally-acting substance discovered by UCB of Belgium in the early 1980s and is an antiepileptic drug which does not share the mechanism of action with any conventional antiepileptic drug.
Globally, it is being marketed under the trade name Keppra® and has over 6.0 million patient-years experience globally . In Japan, it has been marketed in adjunctive therapy for partial onset seizures in adult patients with epilepsy in combination with other antiepileptic drugs since September 2010. Keppra® was first approved in the US in 1999, followed by the EU in 2000, as adjunctive therapy for partial-onset seizures in adults with epilepsy. Since then, it has received several supplemental indications including adjunctive therapy for myoclonic and tonic-clonic seizures in adults as well as partial-onset seizures in pediatric patients in the US and the EU. In the EU, Keppra® is also approved as monotherapy for the treatment of partial-onset seizures in adults with epilepsy.
As of January 2013, it was approved for "adjunctive therapy for partial-onset seizures in adult patients with epilepsy in combination with other antiepileptic drugs" in over 100 countries and regions including the US and the EU. It is also widely used in pediatric patients with approval for "adjunctive therapy for partial- onset seizures in pediatric patients with epilepsy in combination with other antiepileptic drugs" in over 80 countries and regions including the EU.
Information in this news release was current as of the original release date.