Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis

Abbott announced today it has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA(R) (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. In the U.S., JIA is commonly referred to as juvenile rheumatoid arthritis (JRA). The approval is based on safety and efficacy results from a clinical study of JIA patients four to 17 years of age. HUMIRA is the first biologic treatment to receive FDA approval for this condition since 1999, and the first to be administered by injection in these patients once every two weeks.

"The pain and inflammation caused by JIA can be debilitating for some children, making it hard for them to run, jump, play or participate in other activities with children their age," said Daniel J. Lovell, M.D., M.P.H., associate director, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati. "HUMIRA is an important new treatment that gives physicians and families another option that can ease the symptoms of polyarticular JIA."
JIA is the most common chronic rheumatic disease in children with onset before age 16. Typical symptoms include stiffness when awakening, limping, and joint swelling. Any joint can be affected and inflammation may limit the mobility of the affected joints. While it was once believed that most children eventually outgrow JIA, it is now known that between 25 and 70 percent of children with JIA will still have active disease into adulthood.
"The symptoms of JIA can make it difficult for children to experience many of the simple joys of childhood," said John Hardin, M.D., chief scientific officer, Arthritis Foundation. "The Arthritis Foundation welcomes the approval of new therapies that expand effective treatment options for doctors and families, helping children and adolescents to keep their symptoms under control."
JIA is the sixth disease indication for which HUMIRA has received approval since 2002.