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news.Eisai has submitted an application to manufacture and distribute KES524, which the company had been developing in Japan for obesity management, to the Ministry of Health, Labour, and Welfare.
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In a multi-center randomized double blind placebo controlled Phase III study conducted in Japan, 342 obese patients received either KES524 or placebo for 52 weeks. The study demonstrated that KES524, compared with placebo, significantly improved the primary endpoints of change in bodyweight, and percent change in bodyweight, as well as the secondary endpoints of VFA (Visceral Fat Area), HbA1c (Hemoglobin A1c), TG (Triglyceride), and HDL-C (High-density lipoprotein cholesterol).
Sibutramine (KES524), an obesity management treatment based on the mode of action of serotonin and noradrenalin reuptake inhibition in the central nervous system, is approved in 83 countries worldwide. In Japan, Eisai has the rights to develop and market KES524 exclusively under the contract with Abbott.