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Muromonab-CD3
Muromonab-CD3 (trade name Orthoclone OKT3, marketed by Janssen-Cilag) is an immunosuppressant drug given to reduce acute rejection in patients with organ transplants. It is a monoclonal antibody targeted at the CD3 receptor, a membrane protein on the surface of T cells. It was the first monoclonal antibody to be approved for clinical use in humans.〔
==History==
Muromonab-CD3 (OKT3) was approved by the U.S. Food and Drug Administration (FDA) in 1985, making it the first monoclonal antibody to be approved anywhere as a drug for humans. In the European Communities, it was the first drug to be approved under the directive 87/22/EWG, a precursor of the European Medicines Agency (EMEA) centralised approval system in the European Union. This process included an assessment by the Committee for Proprietary Medicinal Products (CPMP, now CHMP), and a subsequent approval by the national health agencies; in Germany, for example, in 1988 by the Paul Ehrlich Institute in Frankfurt. However, the manufacturer of Muromonab-CD3 has voluntarily withdrawn it from the United States market due to decreased utilization; current OKT3 supplies are expected to be exhausted by mid-2010.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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