February 29, 2016
Otsuka Pharmaceutical Co., Ltd.
Anti-epileptic Drug E Keppra® (generic name: levetiracetam) Obtains Additional Indication of Adjunctive Therapy for Generalized Tonic-Clonic Seizures in Japan
- In Japan, E Keppra® is marketed for partial-onset seizures (including secondary generalized seizures) in patients with epilepsy and has been used in over 100,000 patients. It recently obtained an additional indication for adjunctive treatment of generalized tonic-clonic seizures.
- Seizures associated with epilepsy are classified into two types: partial-onset seizures and generalized seizures. Generalized tonic-clonic seizures, which account for 60% of generalized seizures, feature a sudden loss of consciousness associated with generalized rigidity and violent convulsions.
- The Japan Epilepsy Society and the Japanese Society of Child Neurology petitioned the MHLW's Council on Unapproved Drugs and Indications with Unmet Medical Needs, calling for the development and approval of E Keppra® for adjunctive therapy for generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy. Its approval is expected to contribute to the treatment of patients with these seizures.
Otsuka Pharmaceutical Co., Ltd. and UCB Japan Co., Ltd. today announced that E Keppra® was approved in Japan for an additional indication as adjunctive therapy with other anti-epileptic drugs for generalized tonic-clonic seizures in adult patients and pediatric patients aged four years and over with epilepsy showing inadequate responses to other anti-epileptic drugs. Otsuka Pharmaceutical and UCB Japan are engaged in the co-development and co-commercialization of E Keppra® in Japan. The formulations approved 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.
Information in this news release was current as of the original release date.