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Jan 11, 2010

FDA Clears Roche/Chugai’s mAb for Rheumatoid Arthritis

  • FDA approved Roche/Chugai’s Actemra for the treatment of adults with moderate-to-severe active rheumatoid arthritis who have had inadequate response to one or more TNF antagonist therapies. The humanized IL-6 receptor mAb is approved either as monotherapy or in combination with methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

    Actemra will be marketed in the U.S. by Roche’s Genentech subsidiary. Chugai will supply the final formulation of the drug to Roche and receive royalties based on sales.

    Actemra was approved in the EU in January 2009 as RoActemra. It is also sanctioned in other countries including Mexico, India, Brazil, Switzerland, and Australia.

    In Japan, Actemra was first launched by Chugai in June 2005 for Castleman disease. Japanese approval for additional indications including rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis was granted in April 2008.

     



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