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news.Chugai Pharmaceutical and Hoffmann-La Roche have submitted a marketing authorization application to the European Medicines Evaluation Agency for Actemra, which is used to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis.
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Actemra [(tocilizumab (genetical recombination)], created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor.
In Japan, Actemra was launched in June 2005 by Chugai, as an orphan drug for Castleman’s disease, following approval in April, the same year. Subsequently, it was filed for the additional indications of rheumatoid arthritis and systemic onset juvenile idiopathic arthritis in April 2006.
Outside of Japan, five Phase III clinical trials, including extension studies in rheumatoid arthritis are going on in 40 countries involving more than 4,000 patients worldwide under co-development between Chugai and Roche. The submission to the EMEA, following the submission to the FDA on November 19, is based on results and extension studies from four out of five of these trials, and the interim analysis of the remaining ongoing trial.