PFIZER'S CELEBREX APPROVED TO TREAT JUVENILE RA

The FDA has approved Pfizer's Celebrex for the relief of the signs and symptoms of juvenile rheumatoid arthritis (RA) in patients 2 and older. The approval follows the Nov. 29 meeting of FDA's Arthritis Advisory Committee at which the committee voted 15-1 in favor of the approval.

Juvenile RA is an autoimmune disease that affects approximately 30,000 to 60,000 children in the U.S. A 24-week study of Celebrex (celecoxib) involving 242 patients between the ages of 2 and 17 demonstrated its effectiveness in treating juvenile RA. The most commonly reported side effects were cough, cold, upper respiratory tract infection, abdominal pain, headache, fever, nausea, diarrhea and vomiting.

Safety and efficacy were not studied beyond six months, and experience with adults suggests the possibility of longer-term cardiovascular problems. As part of the approval of Celebrex, the Pfizer has agreed to conduct two Phase IV postmarketing studies: a short-term controlled trial to evaluate high blood pressure and a several-year registry study to further evaluate long-term safety issues, including renal toxicity, high blood pressure and cardiovascular events.

Celebrex, a Cox-2 selective non-steroidal anti-inflammatory drug, was originally approved for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis in adults.