ROCKVILLE, Maryland—Moving with what passes for blazing speed in government circles, the US Food and Drug Administration (FDA) has approved celecoxib (Celebrex®, Pfizer) for treatment of juvenile rheumatoid arthritis (JRA). The decision came just 2 weeks after the agency's Arthritis Advisory Committee voted 15-1 to recommend approval for this new indication.

Celebrex, which remains the only coxib approved for use in the US, is expected to be a welcome addition to the treatment options for JRA.

"Celebrex will be a needed additional treatment option for children." —Steven Galson, MD.
"JRA is often a devastating disease. 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," said Steven Galson, MD, director of the FDA's Center for Drug Evaluation and Research.

The new Celebrex indication is for relief of the signs and symptoms of JRA in patients 2 years of age and older. The FDA approval came with a number of cautions, including that the drug has not been studied in the following patient populations of children:

● Those younger than 2 years
● Those weighing less than 22 pounds
● Those with signs of systemic onset RA, such as high fever and rash

"Celebrex should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions, including abnormal clotting tests, which can be associated with the clinical condition known as disseminated intravascular coagulation," the agency warned.

The FDA announcement further notes that safety and efficacy of celecoxib for JRA were not studied beyond 6 months and warns, "[E]xperience with adults suggests the possibility of longer term cardiovascular problems."

To address some of these concerns, Pfizer agreed to conduct two Phase 4 postmarketing studies: a short-term controlled trial to evaluate the risk of high blood pressure in JRA treated with celecoxib, and a several-year registry study to further evaluate long-term safety issues, including renal toxicity, high blood pressure, and cardiovascular events.


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Reference

Celebrex Approved to Treat Juvenile Rheumatoid Arthritis [press release]. Rockville, Maryland: US Food and Drug Administration; December 15, 2006.