March 7, 2014
Otsuka Pharmaceutical Co., Ltd.
UCB Japan Co. Ltd.
Anti-Epileptic Drug E Keppra® Filed in Japan for Additional Indication of Monotherapy for Partial-Onset Seizures
- E Keppra® (brand name outside Japan: Keppra®) was launched in Japan in 2010 as adjunctive therapy with existing anti-epileptic drugs for partial-onset seizures and it now holds the largest value market share among anti-epileptic drugs in Japan*1. An application for regulatory approval has been submitted in Japan for E Keppra® to be used as monotherapy in addition to its current use as adjunctive therapy. Keppra® has accumulated 6 million patient years of use worldwide and is used in more than 100 countries and regions, starting from its 1999 launch in the U.S. The International League Against Epilepsy(ILAE) regards this product as anti-epileptic drug established as efficacious or effective as initial monotherapy*2. In Europe, it is regarded as a first-choice drug in monotherapy.
- Epilepsy is a cranial nerve disorder that occurs in about 1% of individuals regardless of race or gender. It often occurs in children and the elderly. There are approximately one million patients in Japan. Major treatment for epilepsy is with anti-epileptic drugs. When a correct diagnosis is made, with monotherapy 70% of people with epilepsy can enjoy seizure-free lives. However, adverse drug reactions and drug-drug interactions occur with conventional anti-epileptic drugs. Therefore it has been expected that monotherapy with newer anti-epileptic drugs*3 should result in fewer adverse reactions and interactions mentioned above.
- Medical societies involved in epilepsy petitioned the Japanese Ministry of Health, Labor and Welfare's Council on Unapproved Drugs and Indications with Unmet Medical Needs to seek development and approval of E Keppra® for the additional indication of monotherapy in partial-onset seizures. The Council concluded that the indication represented great unmet medical need and issued a call to develop the drug for this indication in April, 2012.
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) have been engaged in co-development and co-marketing of E Keppra® Tablets 250 mg and 500 mg and E Keppra® Dry Syrup 50% (generic name: levetiracetam). A partial amendment application for monotherapy for partial-onset seizures (including secondary generalized seizures) in epilepsy patients has been filed.
Information in this news release was current as of the original release date.