Singapore, July 30, 2008: The Arthritis Advisory Committee of the US Food and Drug Administration (FDA) voted ten to one for the approval of Actemra, the humanized monoclonal antibody, filed with the FDA as a treatment for rheumatoid arthritis (RA) by Japanese firm Chugai Pharmaceutical. The FDA is not bound by the committee's recommendation to approve the drug, however, it generally follows its advice.

 

Actemra, the first antibody drug (humanized monoclonal antibody) originating from Japan, was created by Chugai in collaboration with Osaka University, utilizing genetic recombinant technology to produce a monoclonal antibody against the anti-IL6 receptor. It works by inhibiting biological activity of IL-6 through competitively blocking the binding of IL-6 to its receptor.

 

In Japan, 200mg preparation of 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 approved for the additional indications of RA (including prevention of structural damage of joints), polyarticular-course juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in April 2008. 80mg and 400mg preparations were launched additionally in June 2008.

 

Currently, five phase III clinical trials, including extension studies in RA are going on in 40 countries involving more than 4,000 patients worldwide under co-development between Chugai and Roche. The submissions were made to the FDA and the European Medicines Evaluation Agency (EMEA), based on results and extension studies from four out of five of these trials, and the interim analysis of the remaining ongoing trial.