Chugai Pharmaceutical Co, Ltd and F. Hoffmann-La Roche Ltd announced that FDA has accepted the complete response resubmission that Roche made to the US Food and Drug Administration (FDA) for the Biologics License Application (BLA) for Actemra the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, following the receipt of the Complete Response Letter in September 2008.

The FDA has designated a Class II, or six-month, review timeline for the resubmission, according to Prescription Drug User Fee Act (PDUFA) guidelines. Actemra is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Roche has worked diligently to fulfil the FDA's requirements for Actemra and has submitted the complete response resubmission earlier than anticipated in the third quarter of 2009. As requested by the FDA, key elements of the complete response resubmission include a proposed Risk Evaluation and Mitigation Strategy (REMS) to help ensure that health care professionals prescribe and administer Actemra correctly, and that patients understand the benefits and known and potential risks associated with this medication. The resubmission also includes the requested non-clinical studies evaluating the effect of Actemra on peri- and post-natal development, and fertility.

The BLA for Actemra is based on the results of an extensive multi-national clinical development programme, which included more than 4,000 patients in 41 countries, including the US. These studies demonstrated that Actemra, alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDS), significantly reduced the signs and symptoms of RA, regardless of previous therapy or disease severity, compared to DMARDS alone. In July 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend the approval of Actemra.

Actemra is part of a co-development programme between Roche and Chugai Pharmaceutical Co.