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Update on FDA Registration of Actemra, a Humanized Anti-Human IL-6 Receptor Monoclonal Antibody for Rheumatoid Arthritis
Chugai Pharmaceutical Co., 01/23/09
Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President Osamu Nagayama (hereafter, "Chugai")] and F. Hoffmann-La Roche Ltd. [Head Office: Basel, Switzerland. CEO: Severin Schwan (hereafter "Roche")] announced today that the U.S. Food and Drug Administration (FDA) has provided further guidance on requirements for the Biologics License Application (BLA) for Actemra, the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody as a treatment for moderately to severely active rheumatoid arthritis (RA).
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