FDA accepts file for new Actemra formulation in rheumatoid arthritis

The US Food and Drug Administration (FDA) has accepted Roche and Chugai Pharmaceutical's
application to market a subcutaneous formulation of Actemra for adult rheumatoid arthritis, setting
up possible approval in October.

Actemra (tocilizumab) is already available in the US as an intravenous infusion for adults with
rheumatoid arthritis who cannot be given or do not respond to disease-modifying anti-rheumatic
drugs, as well as systemic juvenile idiopathic arthritis (sJIA).

The new application is based on two Phase III studies - called SUMMACTA and BREVACTA - which
compared the subcutaneous formulation of Actemra with the current monthly infusion schedule or
placebo.