Pfizer Inc. won federal approval Friday to market the painkiller Celebrex as a treatment for the tens of thousands of children with a devastating form of arthritis.
The expanded approval will allow the New York company to promote the drug for juvenile rheumatoid arthritis in patients 2 and older. The drug already is used off-label by some doctors as a treatment for the disease, which affects up to 60,000 U.S. children.
"JRA is often a devastating disease," said Dr. Steven Galson, director of the Food and Drug Administration'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."
The decision comes after FDA advisers recommended Nov. 29 the drug as an effective but not necessarily safe treatment for the autoimmune disease, but said that its benefits still outweigh any risks.
The FDA said it would require Pfizer to continue studying the safety of the drug in children, including its long-term effect on the kidneys, blood pressure and heart.
Celebrex is the only member of the class of drugs that included Vioxx and Bextra not to have been withdrawn from the market over concerns they elevate the risk of heart attacks and strokes in adults. An earlier FDA review questioned the cardiovascular risks of long-term use of the drug in children.
Pfizer presented the FDA with the results of a six-month study showing that Celebrex, also known as celecoxib, works just as well as naproxen in treating young patients with rheumatoid arthritis. Naproxen, sold as Aleve and in generic versions, has been the most common treatment for JRA.
Vioxx, until it was withdrawn in 2004, had been the only FDA-approved drug of its class for the disease.
The FDA originally approved Celebrex for use in adults with osteoarthritis and rheumatoid arthritis in 1998. The drug is a COX-2 selective nonsteroidal anti-inflammatory, or NSAID.
The drug has not been studied in children younger than 2 nor in patients with a more serious type of the disease called systemic onset JRA, the FDA cautioned.