June 28, 2013
Otsuka Pharmaceutical Co., Ltd.
UCB Japan Co. Ltd.
Two New Formulations of E Keppra® Developed Dry Syrup Obtains Approval; Application Filed for Injectable FormulationAddress various needs of patients with epilepsy from 4 years of age and contribute to improvement of compliance with medication
- Epilepsy is a cranial nerve disease with a relatively high incidence、 affecting about 1 in 100 people. Epilepsy has a relatively high incidence in children and elderly (please refer to graph below.) It is difficult to predict when seizures will occur and continual administration of anti-epileptic drugs is critical. Through continual treatment with anti-epileptic drugs, over 70% of patients can lead seizure-free lives.
- E Keppra® Dry Syrup 50% contributes to better compliance in pediatric patients and in adult patients who experience difficulty swallowing tablets. It can be readily taken by pediatric epilepsy patients since it dissolves easily and has an improved taste as a result of the addition of a sweetener. Its dosage can easily be adjusted to body weight.
- The injectable formulation of E Keppra® (levetiracetam;) can be used in patients who transiently experience difficulty taking drugs orally due to surgery and GI disorders associated with intercurrent diseases. It is therefore expected to help continuously prevent seizures in these patients.
- Keppra® (levetiracetam; brand name in Japan is E Keppra®) was first approved in the U.S. in 1999 as adjunctive therapy for partial-onset seizures in adults with epilepsy. It has been approved in over 100 countries and regions. Levetiracetam can be used by patients of nearly all ages and is one of the world's most frequently-prescribed antiepileptic drugs.
Otsuka Pharmaceutical Co., Ltd. (head office: Tokyo; President and Representative Director: Taro Iwamoto) and UCB Japan Co., Ltd. (head office: Tokyo; President and Representative Director: Joel Peterson) received marketing authorization from the Japanese Ministry of Health, Labor and Welfare (MHLW) for E Keppra® Dry Syrup 50% on June 28. In addition, the two companies submitted an application for marketing authorization for "Levetiracetam Injection" in June.
Information in this news release was current as of the original release date.