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

February 20, 2015

Novel Anti-epileptic Drug E Keppra® Approved in Japan for Additional Indication as Monotherapy for Partial-onset Seizures, in Addition to Existing Indication as Adjunctive Therapy for These Seizures

  • E Keppra® recently obtained an additional indication of monotherapy, making it possible to use it to treat partial-onset seizures in all patients aged four years and over. The anti-epileptic drug E Keppra® has the top share in Japan*1 and has been used in over 100,000 patients. Overseas therapeutic 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 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. For this reason, new anti-epileptic drugs devoid of problems such as adverse drug reactions and drug-drug interactions and that make monotherapy*3 possible 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 for the development and approval of E Keppra® for 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 for 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 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 therapy for partial-onset seizures. UCB Japan filed an application for a partial amendment of approval to use levetiracetam in monotherapy. The partial amendment has been approved for monotherapy for 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, reprinted with permission, all rights reserved
  2. 2Overseas Guidelines including the International League Against Epilepsy (ILAE), Epilepsia 54 (3) 551-563; 2013, and UK NICE 2012
  3. 3Newer anti-epileptic drugs launched in Japan since 2006, including E Keppra