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12-27-2005: Eisai Co., Ltd and Abbott Japan Co., Ltd submitted a new drug application (NDA) to the Minister of Health Labour and Welfare (MHLW) for the manufacturing and marketing for the rheumatoid arthritis drug adalimumab (D2E7), which is co-developed by the two companies in Japan.
Adalimumab (D2E7) resembles antibodies normally found in the human body. It works by neutralizing TNF-alpha, a protein that plays a central role in the inflammatory responses of autoimmune disease such as rheumatoid arthritis.
Clinical trials for adalimumab (D2E7) have been conducted in Japan since 2000. The clinical trials have explored adalimumab's (D2E7) effectiveness in treating autoimmune disorders such as rheumatoid arthritis. Approximately 400 Japanese patients have participated in the trials.
Adalimumab (D2E7) is the only fully human monoclonal antibody approved by the United States Food and Drug Administration and the European Medicines Agency for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Abbott markets adalimumab (D2E7) in the U.S. and European Union under the brand name of HUMIRA(R).
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