Orencia approved by FDA to treat juvenile arthritis

WASHINGTON The Food and Drug Administration has approved Bristol-Myers Squibb’s rheumatoid arthritis drug Orencia for the treatment of juvenile rheumatoid arthritis in children aged 6 and older.

Juvenile rheumatoid arthritis is the most common form of arthritis in children. According to the American College of Rheumatology, the disabling autoimmune disease affects about one in every 1,000 children in the U.S. Symptoms range from mild to severe and may include chronic pain, joint swelling, stiffness, joint deformities, and soft tissue damage.

The FDA based its pediatric approval on results from a trial known as AWAKEN. The three-part study evaluated the safety and effectiveness of the drug in patients ages 6 to 17 who had moderately to severely active juvenile rheumatoid arthritis for an average of four years and whose symptoms did not subside when given one or more disease-modifying antirheumatic drugs such as methotrexate and anti-TNF drugs, which target an inflammatory protein called TNF (tumor necrosis factor).

The 190 patients enrolled in the first part of the study received Orencia every 14 days for the first month and then every month thereafter. The drug consistently improved symptoms.