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

March 26, 2015

Novel Anti-epileptic Drug E Keppra® Filed in Japan for Additional Indication of Adjunctive Therapy for Generalized Tonic-clonic Seizures

  • In Japan, E Keppra® has been marketed for partial-onset seizures (including secondary generalized seizures) in patients with epilepsy and has been used in over 100,000 patients as an anti-epileptic drug. An application has now been submitted to Japan's Pharmaceutical and Medical Devices Agency for the additional indication of adjunctive therapy for generalized tonic-clonic seizures.
  • Epilepsy is classified into two types: partial epilepsy and generalized epilepsy. There are approximately one million patients with epilepsy in Japan. Generalized tonic-clonic seizures feature a loss of consciousness and violent muscle contraction. Patients suddenly lose consciousness and rhythmic musclar contractions. Patients with these seizures account for 60% of patients with generalized epilepsy.
  • Requests to develop E Keppra® and apply for regulatory approval for adjunctive therapy for generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy were presented to the Japanese Ministry of Health, Labour and Welfare's Council on Unapproved Drugs and Indications with Unmet Medical Needs. An application was filed for adjunctive therapy for generalized tonic-clonic seizures, based on clinical data that support the efficacy of E Keppra® for this indication.

Otsuka Pharmaceutical Co., Ltd. and UCB Japan Co., Ltd. have been engaged in co-development and co-marketing of E Keppra® (generic name: levetiracetam) in Japan. UCB Japan filed an application for a partial change of approval to use levetiracetam in adjunctive therapy with other anti-epileptic drugs for generalized tonic-clonic seizures in adult patients and pediatric patients aged four years and over with generalized epilepsy. The products filed for this indication include E Keppra® Tablets 250 mg and 500 mg, E Keppra® Dry Syrup 50%, and E Keppra® for IV Infusion 500 mg*.

  • Not yet listed in the drug tariff