FDA Deems Arthritis Medicine Prexige "Not Approvable"

Wednesday October 3, 2007

Prexige (lumiracoxib), a medicine being developed by Novartis as a once-daily treatment for arthritis patients with osteoarthritic pain, has not been approved by the U.S. Food and Drug Administration (FDA). On September 27, 2007, Novartis received a "not approvable" letter from the FDA. Prexige is a COX-2 selective inhibitor, the same class of arthritis medications as Vioxx. Due to increased cardiovascular risks, Vioxx (rofecoxib) was removed from the market in 2004. The FDA has turned down Prexige pending more data on the potential effects on the liver, according to Novartis.

Prexige is approved in more than 50 countries but this year Australia recalled the drug following 8 severe adverse events involving liver damage. The FDA made its decision following analysis of clinical trial data which involved about 40,000 patients. Studies have shown that Prexige reduced gastrointestinal complications compared to two other commonly used nonsteroidal anti-inflammatory drugs (NSAIDs). Prexige also had smaller increases in blood pressure than naproxen and ibuprofen and no significant difference in heart risks. Less than one percent of patients taking 100 mg. once-daily in another study had liver enzyme elevations that were 3 times the upper limit of normal.

Novartis plans to continue discussions with the FDA because it considers Prexige a valuable treatment option for appropriate patients with osteoarthritis, after doctors and patients consider individual risks versus benefits. Patients at risk for developing ulcers and those on anticoagulant therapy (blood thinners) may be appropriate patients.

More Related Resources:

Join the Discussion: