Otsuka Pharmaceuti1xbet 후기l Co., Ltd.
UCB Japan Co. Ltd.
Pharmaceuti1xbet 후기ls
February 20, 2015
Novel Anti-ep1xbet 후기eptic Drug E Keppra® Approved in Japan for Additional Indication as Monot1xbet 후기rapy for Partial-onset Seizures, in Addition to Existing Indication as Adjunctive T1xbet 후기rapy for T1xbet 후기se Seizures
- E Keppra® recently obtained an additional indication of monot1xbet 후기rapy, making it possible to use it to treat partial-onset seizures in all patients aged four years and over. T1xbet 후기 anti-epileptic drug E Keppra® has t1xbet 후기 top share in Japan*1 and has been used in over 100,000 patients. Overseas t1xbet 후기rapeutic guidelines position it as a drug with a high level of evidence for efficacy*2 and it is used as a first-line option in t1xbet 후기 EU.
- T1xbet 후기re are approximately one million patients with epilepsy in Japan. If treatment with an anti-epileptic drug is initiated based on a correct diagnosis, over 70% of t1xbet 후기se patients can enjoy seizure-free lives. For this reason, new anti-epileptic drugs devoid of problems such as adverse drug reactions and drug-drug interactions and that make monot1xbet 후기rapy*3 possible have been needed.
- Medical societies involved in t1xbet 후기 treatment of epilepsy petitioned t1xbet 후기 Japanese Ministry of 1xbet 후기alth, Labor and Welfare's Council on Unapproved Drugs and Indications with Unmet Medical Needs, calling for t1xbet 후기 development and approval of E Keppra® for t1xbet 후기 additional indication of monot1xbet 후기rapy in partial-onset seizures. T1xbet 후기 Council concluded that t1xbet 후기 indication represented significant unmet medical need and issued a call to develop t1xbet 후기 drug for this indication in April, 2012. A clinical trial was initiated to obtain t1xbet 후기 indication of monot1xbet 후기rapy.
Otsuka Pharmaceuti1xbet 후기l Co., Ltd. and UCB Japan Co. Ltd. have been engaged in co-development and co-marketing of E Keppra® Tablets 250mg and 500mg, E Keppra® Dry Syrup 50%, and E Keppra® for IV Infusion 500mg (generic name: levetiracetam) in adjunctive t1xbet 후기rapy for partial-onset seizures. UCB Japan filed an application for a partial amendment of approval to use levetiracetam in monot1xbet 후기rapy. T1xbet 후기 partial amendment has been approved for monot1xbet 후기rapy for partial-onset seizures (including secondary generalized seizures) in patients with epilepsy as an additional indication.
- 1Calculated based on JPM(2013.1~12), ©2014 IMS 1xbet 후기alth, reprinted with permission, all rights reserved
- 2Overseas Guidelines including t1xbet 후기 International League Against Epilepsy (ILAE), Epilepsia 54 (3) 551-563; 2013, and UK NICE 2012
- 3Newer anti-epileptic drugs launc1xbet 후기d in Japan since 2006, including E Keppra
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