Roche, Chugai File Actemra Application

Japan’s Chugai Pharmaceutical and Swiss drugmaker Roche have submitted a marketing authorization application to the European Medicines Evaluation Agency (EMEA) for Actemra, a treatment for moderate to severe rheumatoid arthritis.

Actemra (tocilizumab) was developed by Chugai in collaboration with Osaka University.

The drug was launched in Japan in June 2005 as a treatment for Castleman’s disease. It was approved for rheumatoid arthritis and systemic onset juvenile idiopathic arthritis in April 2006.

The EMEA submission follows a Nov. 19 submission to the FDA and is based on results and extension studies from four Phase III studies and the interim analysis of a fifth Phase III trial, Chugai said.