Actemra Receives FDA Approval for Rheumatoid Arthritis

Actemra, a once-a-month infusion from Genentech, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody -- a new class of biologic drugs.  Actemra will be available in doctors' offices, hospitals, and infusion centers this month.

Actemra, also known as tocilizumab, is the first medication to specifically inhibit the biological activity of IL-6, a common protein found in the joints that can cause swelling and inflammation.  While everyone has IL-6 in their body, people with RA may have too much, causing the immune system to attack and destroy the joints.  Actemra works by blocking the action of IL-6 in the body.

The Actemra clinical development program included five phase III studies with more than 4,000 patients.  The studies showed that people with RA who received either a 4 mg/kg or 8 mg/kg dose of Actemra -- alone or in combination with methotrexate or other DMARDs -- had significantly reduced disease symptoms despite treatment with existing therapies compared with people who only received DMARDs.

The overall safety profile of Actemra was consistent across all studies.  More information about Actemra is available online at actemra.com.