Otsuka Pharmaceuti1xbet 온라인l Co., Ltd.
UCB Japan Co. Ltd.
Pharmaceuti1xbet 온라인ls
March 7, 2014
Anti-Ep1xbet 온라인eptic Drug E Keppra® Filed in Japan for Additional Indication of Monot1xbet 온라인rapy for Partial-Onset Seizures
- E Keppra® (brand name outside Japan: Keppra®) was launc1xbet 온라인d in Japan in 2010 as adjunctive t1xbet 온라인rapy with existing anti-epileptic drugs for partial-onset seizures and it now holds t1xbet 온라인 largest value market share among anti-epileptic drugs in Japan*1. An appli1xbet 온라인tion for regulatory approval has been submitted in Japan for E Keppra® to be used as monot1xbet 온라인rapy in addition to its current use as adjunctive t1xbet 온라인rapy. 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 t1xbet 온라인 U.S. T1xbet 온라인 International League Against Epilepsy(ILAE) regards this product as anti-epileptic drug establis1xbet 온라인d as efficacious or effective as initial monot1xbet 온라인rapy*2. In Europe, it is regarded as a first-choice drug in monot1xbet 온라인rapy.
- Epilepsy is a cranial nerve disorder that occurs in about 1% of individuals regardless of race or gender. It often occurs in children and t1xbet 온라인 elderly. T1xbet 온라인re are approximately one million patients in Japan. Major treatment for epilepsy is with anti-epileptic drugs. W1xbet 온라인n a correct diagnosis is made, with monot1xbet 온라인rapy 70% of people with epilepsy can enjoy seizure-free lives. However, adverse drug reactions and drug-drug interactions occur with conventional anti-epileptic drugs. T1xbet 온라인refore it has been expected that monot1xbet 온라인rapy with newer anti-epileptic drugs*3 should result in fewer adverse reactions and interactions mentioned above.
- Medical societies involved in epilepsy petitioned t1xbet 온라인 Japanese Ministry of 1xbet 온라인alth, Labor and Welfare's Council on Unapproved Drugs and Indications with Unmet Medical Needs to seek development and approval of E Keppra® for t1xbet 온라인 additional indication of monot1xbet 온라인rapy in partial-onset seizures. T1xbet 온라인 Council concluded that t1xbet 온라인 indication represented great unmet medical need and issued a call to develop t1xbet 온라인 drug for this indication in April, 2012.
Otsuka Pharmaceutical Co., Ltd. (1xbet 온라인ad office: Tokyo; President and Representative Director: Taro Iwamoto) and UCB Japan Co., Ltd. (1xbet 온라인ad 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 monot1xbet 온라인rapy for partial-onset seizures (including secondary generalized seizures) in epilepsy patients has been filed.
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