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 neutralising TNF- a protein that plays a central role in the inflammatory responses of autoimmune disease such as rheumatoid arthritis, states a company release.
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.
In Japan, there are estimated to be approximately 700,000 patients with rheumatoid arthritis. Eisai and Abbott Japan are making every effort to obtain early approval for the drug in order to bring the benefits of adalimumab (D2E7) to patients with rheumatic disease as soon as possible.
Rheumatoid arthritis is an inflammatory disease that causes inflammation and swelling of many joints. Long-term progression of joint damage may often cause deformation and dysfunction of joints.
Eisai Co. Ltd. is a research-based human health care company that discovers, develops and markets products in more than 30 countries.