The Food and Drug Administration says
pain reliever Celebrex can be used to treat juvenile rheumatoid arthritis, the seventh FDA-approved indication for the drug.
The agency, which announced its decision late Friday afternoon, acted less than three weeks after a panel of outside medical advisors recommended that Celebrex be allowed for JRA in patients two years and older. The FDA says this inflammatory disease affects approximately 30,000 to 60,000 U.S. children, causing pain, swelling of joints, decreased range of motion and growth abnormalities.
"JRA is often a devastating disease," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research, in a prepared statement Friday. "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."
An FDA advisory panel supported Celebrex for juvenile rheumatoid arthritis on Nov. 29 by a 15-to-1 vote. But the panel also voted 8 to 7, with one abstention, that Pfizer¿s testing didn¿t clearly prove the drug¿s safety for these young patients. An FDA staff report issued before the committee¿s vote said Pfizer¿s testing guidelines for juvenile rheumatoid arthritis "may not be adequate." Safety and efficacy were not studied beyond six months.
Celebrex¿s approved uses include the inflammatory disease rheumatoid arthritis, management of acute pain in adults, the degenerative joint disease osteoarthritis and the reduction of certain colon polyps.
Celebrex is a COX-2 inhibitor, the same class of drugs that includes Bextra, which Pfizer removed from the market last year because the FDA said its risks outweighed its benefits.
Another COX-2 inhibitor is Vioxx, which
withdrew from the market in September 2004. Merck acted after a company-sponsored clinical trial showed a higher risk of cardiovascular risk in Vioxx users vs. people who received a placebo. Merck says the risk was statistically significant for people who took Vioxx for more than 18 months.
Pfizer shares ended Friday up 8 cents at $25.64.