FDA approval could await new RA treatment

The family of drugs treating rheumatoid arthritis (RA) could grow by one in the future if drug manufacturer Roche's FDA application is approved. The Switzerland-based company has submitted a biologics license application (BLA) to the Food and Drug Administration (FDA) for Actemra (tocilizumab) -- a drug Roche says can reduce moderate to severe RA symptoms in adults.

This is the first drug of its kind seeking approval to treat RA. Medicalnewstoday.com describes the drug as "the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody." Impeding IL-6 cytokines -- pro-inflammatory cell secretions -- "may reduce inflammation of the joints and relieve certain systemic effects of RA."

William M. Burns, CEO of the Pharmaceuticals Division at Roche, said, "The filing for Actemra in the U.S. is an important milestone for Roche, and brings us another step closer to making this therapy available to the millions of patients in the United States who suffer from the pain and debilitating effects of rheumatoid arthritis."

The BLA submission to the FDA is based on results from five international Phase III studies which demonstrated Actemra as monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate significantly reduced the signs and symptoms of rheumatoid arthritis, as measured by the American College of Rheumatology (ACR) and disease activity score (DAS) remission rates, compared with DMARD therapies alone. Furthermore, patients who had previously failed anti-tumor necrosis factor (anti-TNF) treatments also showed significant improvement in signs and symptoms of RA after treatment with Actemra.

To read more about Actemra, including its reported side effects in clinical trials, click on the link below.

Article References
Roche Submits Application For FDA Approval Of Actemra For The Treatment Of Rheumatoid Arthritis, site accessed on 12/03/07