Chugai files Actemra for rheumatoid arthritis in Europe

Chugai Pharmaceutical and Roche have announced the submission of a marketing authorisation application to the European Medicines Evaluation Agency for Actemra (tocilizumab) as a treatment for the signs and symptoms of rheumatoid arthritis.

The compound is a humanised anti-human interleukin-6 (IL-6) receptor monoclonal antibody developed by Chugai in partnership with Osaka University, using genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody.

It competitively blocks the binding of IL-6 to its receptor in order to inhibit IL-6 biological activity.

Actemra was launched in Japan as an orphan drug for Castleman’s disease in June 2005 and was filed for 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 company reports.

It adds that this submission in Europe is based on the results of four of these trials an an interim analysis of the fifth study that is still continuing.

In May 2007, Chugai announced that it would co-promote Actemra with Roche in the UK, France and Germany, though not in Italy, Spain or the US.