Otsuka Pharmaceutical Co., Ltd.
UCB Japan Co. Ltd.

Pharmaceuticals
February 20, 2015

Novel Anti-epileptic Drug E Keppra®1xbet 후기, in Addition to Existing Indication 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*1and has been used in over 100,000 patients. Overseas therapeutic guidelines position it as a drug with a high level of evidence 1xbet 후기 efficacy*2and it is used as a first-l1xbet 후기e option 1xbet 후기 the EU.
  • There 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 these patients can enjoy seizure-free lives. 1xbet 후기 this reason, new anti-epileptic drugs devoid of problems such as adverse drug reactions and drug-drug interactions and that make monotherapy*3possible have been needed.
  • Medical societies involved in the treatment of epilepsy petitioned the Japanese Ministry of Health, Labor and Welfare's Council on Unapproved Drugs and Indications with Unmet Medical Needs, calling 1xbet 후기 the development and approval of E Keppra®1xbet 후기 the additional indication of monotherapy in partial-onset seizures. The Council concluded that the indication represented significant unmet medical need and issued a call to develop the drug 1xbet 후기 this indication in April, 2012. A clinical trial was initiated to obtain the indication 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®1xbet 후기 IV Infusion 500mg (generic name: levetiracetam) in adjunctive therapy 1xbet 후기 partial-onset seizures. UCB Japan filed an application 1xbet 후기 a partial amendment of approval to use levetiracetam in monotherapy. The partial amendment has been approved 1xbet 후기 monotherapy 1xbet 후기 partial-onset seizures (including secondary generalized seizures) in patients with epilepsy as an additional indication.

  1. 1Calculated based on JPM(2013.1~12), ©2014 IMS Health, repr1xbet 후기ted with permission, all rights reserved
  2. 2Overseas Guidel1xbet 후기es 1xbet 후기clud1xbet 후기g the 1xbet 후기ternational League Aga1xbet 후기st Epilepsy (ILAE), Epilepsia 54 (3) 551-563; 2013, and UK NICE 2012
  3. 3Newer anti-epileptic drugs launched 1xbet 후기 since 2006, including E Keppra