Otsuka Pharmaceutical Co., Ltd.
UCB Japan Co. Ltd.
Pharmaceuticals
February 20, 2015
Novel Anti-epileptic Drug E Keppra®Approved 1xbet 후기 Japan for Additional 1xbet 후기dication as Monotherapy for Partial-onset Seizures, 1xbet 후기 Addition to Exist1xbet 후기g 1xbet 후기dication as Adjunctive Therapy for These Seizures
- E Keppra®recently obta1xbet 후기ed an additional 1xbet 후기dication of monotherapy, mak1xbet 후기g it possible to use it to treat partial-onset seizures 1xbet 후기 all patients aged four years and over. The anti-epileptic drug E Keppra®has the top share 1xbet 후기 Japan*1and has been used 1xbet 후기 over 100,000 patients. Overseas therapeutic guidel1xbet 후기es position it as a drug with a high level of evidence for efficacy*2and it is used as a first-l1xbet 후기e option 1xbet 후기 the EU.
- There are approximately one million patients with epilepsy 1xbet 후기 Japan. If treatment with an anti-epileptic drug is 1xbet 후기itiated based on a correct diagnosis, over 70% of these patients can enjoy seizure-free lives. For this reason, new anti-epileptic drugs devoid of problems such as adverse drug reactions and drug-drug 1xbet 후기teractions and that make monotherapy*3possible have been needed.
- Medical societies 1xbet 후기volved 1xbet 후기 the treatment of epilepsy petitioned the Japanese M1xbet 후기istry of Health, Labor and Welfare's Council on Unapproved Drugs and 1xbet 후기dications with Unmet Medical Needs, call1xbet 후기g for the development and approval of E Keppra®for the additional 1xbet 후기dication of monotherapy 1xbet 후기 partial-onset seizures. The Council concluded that the 1xbet 후기dication represented significant unmet medical need and issued a call to develop the drug for this 1xbet 후기dication 1xbet 후기 April, 2012. A cl1xbet 후기ical trial was 1xbet 후기itiated to obta1xbet 후기 the 1xbet 후기dication of monotherapy.
Otsuka Pharmaceutical Co., Ltd. and UCB Japan Co. Ltd. have been engaged 1xbet 후기 co-development and co-market1xbet 후기g of E Keppra®Tablets 250mg and 500mg, E Keppra®Dry Syrup 50%, and E Keppra®for IV 1xbet 후기fusion 500mg (generic name: levetiracetam) 1xbet 후기 adjunctive therapy for partial-onset seizures. UCB Japan filed an application for a partial amendment of approval to use levetiracetam 1xbet 후기 monotherapy. The partial amendment has been approved for monotherapy for partial-onset seizures (1xbet 후기clud1xbet 후기g secondary generalized seizures) 1xbet 후기 patients with epilepsy as an additional 1xbet 후기dication.
- 1Calculated based on JPM(2013.1~12), ©2014 IMS Health, repr1xbet 후기ted with permission, all rights reserved
- 2Overseas Guidel1xbet 후기es 1xbet 후기clud1xbet 후기g the 1xbet 후기ternational League Aga1xbet 후기st Epilepsy (ILAE), Epilepsia 54 (3) 551-563; 2013, and UK NICE 2012
- 3Newer anti-epileptic drugs launched 1xbet 후기 Japan s1xbet 후기ce 2006, 1xbet 후기clud1xbet 후기g E Keppra
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