EISAI TO WITHDRAW JAPAN MARKETING AUTHORIZATION APPLICATION FOR ANTIOBESITY AGENT KES524
Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) announced today that it has decided to withdraw the Marketing Authorization Application (MAA) and discontinue development of the antiobesity agent KES524 (generic name: sibutramine hydrochloride monohydrate).
Eisai obtained the exclusive rights to develop and market KES524 in Japan in an agreement with Abbott and submitted a MAA for the agent to the Japanese regulatory authorities in November 2007 based on results of clinical studies it conducted in Japan. However, the company has decided to withdraw the MAA and discontinue the development of KES524 following Abbott's recent suspension/withdrawal of the drug from some global markets including the U.S., and Europe.
Public Relations Department,
Eisai Co., Ltd.