Eisai Recieves A Positive Opinion for Zonegran Marketing Authorization From European Committee For Medicinal Products for Human Use (CHMP)
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that on December 15 (U.K. time) its UK subsidiary Eisai Ltd. (Headquarters: London, Managing Director: Paul Hooper) received a positive opinion for Zonegran (zonisamide), an anti-epileptic drug for the adjunctive therapy of partial seizures in adults, from the Committee for Medicinal Products for Human Use (CHMP), the scientific body of the European Medicines Evaluation Agency (EMEA).
In April 2004, Eisai obtained manufacturing, developing and marketing rights for Zonegran in Europe. Eisai Ltd. received a positive opinion by the CHMP for Zonegran, whose Marketing Authorization Application was submitted through the European Union's (EUs) Centralized Procedure in November 2003 by Elan.
Major characteristics of Zonegran are that it has a wide anti-seizure spectrum and its unfavourable drug-drug interactions with other anti-epileptic drugs are minimal. Zonegran was approved and launched in March 2000 in the U.S. for adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Eisai Inc., a subsidiary in the U.S., has been marketing the product since the end of April 2004. In Japan, the product was approved in 1989 and is marketed by Dainippon Pharmaceutical Co., Ltd. under the brand name Excegran.
Based on the receipt of this positive opinion, Eisai will strengthen its neurology product pipeline and aim at expanding business opportunities in Europe in order to fulfil patients' needs and contribute to their benefits.
Eisai Co., Ltd.
Corporate Communications Department
Phone 03-3817-5120 (Tokyo)
[Summaries of CHMP recommendation for Zonegran follows]
< Note to the editor >
[CHMP recommendation for Zonegran]