Drug Litigation Newsroom

Celebrex Approved to Treat Juvenile Rheumatoid Arthritis

The U.S. Food and Drug Administration (FDA) today approved Celebrex (celecoxib) for a new use – the relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients two years of age and older. Today's approval follows the November 29 meeting of FDA's Arthritis Advisory Committee, in which the committee voted 15 to 1 in favor of approval of this product.

JRA is an autoimmune disease that affects approximately 30,000 to 60,000 children in the United States. The disease is associated with joint swelling, pain, decreased range of motion and abnormalities of growth and development. In some cases, systemic complications may occur including uveitis, a chronic inflammation of the eye. In severe, uncontrolled cases, permanent disability may occur due to progressive joint damage.

“JRA is often a devastating disease,” said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research. “While there are other medicines approved for the treatment of this disorder, for some children they may have limited effectiveness or cause intolerable side effects. Celebrex will be a needed additional treatment option for children.”

A 24-week study of Celebrex involving 242 patients between the ages of two and 17 years demonstrated its effectiveness in treating JRA. The most commonly reported side effects were cough, cold, upper respiratory tract infection, abdominal pain, headache, fever, nausea, diarrhea and vomiting. Read more at fda.gov