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  5. UCB Japan Files for Indication of Pediatric Epilepsy (Partial Onset Seizures) for E Keppra® Tablet; New Dry Syrup Formulation Filed at the Same Time

June 21, 2012

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

UCB Japan Files for Indication of Pediatric Epilepsy
(Partial Onset Seizures) for E Keppra® Tablet;
New Dry Syrup Formulation Filed at the Same Time

  • UCB Japan Files for Additional Dosage and Administration for E Keppra Tablet as Adjunctive Therapy in Combination with Other Antiepileptic Drugs in the treatment of Partial Onset Seizures in Children as from 4 years of age with Epilepsy
  • Application for Japan's First Dry Syrup*1 Formulation for an Antiepileptic Drug at the Same Time

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) filed in June 2012 for an additional dosage and administration for the antiepileptic drug E Keppra 250 mg and 500 mg Tablet (levetiracetam) as an adjunctive therapy in combination with other antiepileptic drugs in the treatment of partial onset seizures in pediatric epilepsy in Japan. The company filed for approval of a new dry syrup formulation E Keppra Dry Syrup 50% at the same time.

  • *1:Dry syrup: A formulation supplied in the form of powder or granules which is flavored or sweetened to make it pleasant to take even for children and the elderly.

Epilepsy may occur at any age, but it occurs most frequently in infants and the elderly. Needs of patients with epilepsy for antiepileptic drugs indicated not only for adults but also children have not been fully met.

E Keppra has a different mechanism of action from other antiepileptic drugs. In Europe and United States, it is prescribed as an adjunctive therapy in the treatment for partial onset seizure in both children and adults with epilepsy. In Japan, its pediatric use has not been approved, so the medical community has asked that it be developed for a pediatric indication in Japan as well.

UCB Japan filed for the pediatric indication based on the results of clinical trials of the dry syrup and tablet formulations in the treatment of adjunctive therapy of partial onset seizures in children with epilepsy. The company also filed for the dry syrup as a new formulation which is more appropriate for children administration.

Otsuka Pharmaceutical and UCB Japan aim to contribute to the treatment of epilepsy and other CNS diseases.

About E Keppra®

E Keppra® (non-proprietary name: levetiracetam) is an antiepileptic drug with over 5.4 million patient-year experience globally and is being marketed under the brand name Keppra® outside Japan. 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 (aged one month or older) 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.
Reference:
Europe:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/
human/000277/WC500041334.pdf

US:http://www.ucb.com/_up/ucb_com_products/documents/Keppra_Labeling_12_2011.pdf


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

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