Actemra®/RoActemra
(tocilizumab)
About Actemra
Actemra (marketed as RoActemra in Europe) is a humanized monoclonal antibody that binds to and inhibits interleukin-6 (IL-6) for the treatment of rheumatoid arthritis (RA). RA is a chronic inflammatory disease of joint synovial tissue, leading to painful disability if left untreated. Actemra is the result of a collaboration between Chugai and Roche and is being co-developed globally by them. An extensive clinical development program of five Phase 3 trials was designed to evaluate clinical findings of Actemra, all of which met their primary endpoint. Actemra, which is currently approved in Japan and the EU for moderate to severe RA, is marketed in Japan by Chugai and in the rest of the world by Roche.
How Actemra Works
Actemra targets the IL-6 receptor to prevent inflammatory cascades involving multiple cell types. As recombinant humanized monoclonal antibody against the human interleukin-6 receptor, Actemra would be the first interleukin inhibitor indicated for RA. IL-6 accelerates the inflammatory cascade by mediating T lymphocyte activation, maturation of megakaryocytes, B cell autoantibody and immunoglobulin production, hepatocyte production of acute phase reactants, and osteoclast activation.
Current Indications
Actemra was first approved in Japan and launched by Chugai in June 2005 as a therapy for Castleman’s disease. In April 2008, additional indications for RA, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. RoACTEMRA (the name for Actemra in Europe) was approved in January 2009 in the EU for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDS) or TNF inhibitors. The drug is also approved for use in several other countries, including India, Brazil, Switzerland and Australia.
Clinical Trials
In late July 2009, Roche announced that the USFDA had accepted its resubmission of application for approval of Actemra for RA. Under the Prescription Drug User Fee Act, USFDA should complete its review of the resubmission by January 2010.