Pfizer Inc. may fall short in convincing federal regulators that its painkiller Celebrex should receive expanded approval to treat children with a devastating form of arthritis, according to documents released Tuesday.
Pfizer wants Food and Drug Administration approval to sell Celebrex as a treatment for juvenile rheumatoid arthritis, or JRA, which affects as many as 60,000 U.S. children. The disease causes painful joint swelling and can affect growth and development.
However, an FDA review of the New York company's application questions whether the drug works for the pediatric disease. The FDA approved the drug for use in adults with osteoarthritis and rheumatoid arthritis in 1998.
FDA's independent advisers will review the issue on Wednesday. The FDA isn't required to follow the panel's advice but usually does.
Celebrex is the only member of a class of drugs that included Vioxx and Bextra not to have been withdrawn from the market over concerns they elevate the risk of heart attacks and strokes in adults.
While acknowledging that risk, Pfizer provided results of a study showing that Celebrex, also known as celecoxib, works just as well as naproxen in treating young rheumatoid arthritis patients.
But FDA documents say limitations to the study's design 'raise questions about whether it provides adequate evidence of efficacy of celecoxib' in the children's disease. Agency reviewers also questioned the cardiovascular risks of long-term use of the drug in children, suggesting more study is needed.
Pfizer said the study results indicate Celebrex would be an appropriate treatment option, and that the drug's effect is comparable to naproxen but gentler on the stomach.
Today, children account for less than half of 1 percent of the prescriptions dispensed for Celebrex. While some already take Celebrex for JRA, surveys suggest orthopedic surgeons are the most common prescribers of the drug for kids, typically to treat sprains and injuries, the FDA said.
source - AP