FDA Rejects Novartis’ Cox-2 Inhibitor Prexige

Novartis has received a not-approvable letter from the FDA for its Cox-2 inhibitor Prexige as a once-daily treatment for osteoarthritic pain.

The FDA noted it remained open to exploring Prexige (lumiracoxib) use for patients in whom the drug would provide an acceptable risk-benefit balance. This group could include patients with a higher incidence of gastrointestinal complications, including those suffering from ulcers or being treated with anticoagulants.

The drug is approved in more than 50 countries, Novartis said. Recently, regulatory authorities in several countries have been questioning the safety of Prexige due to reports of severe liver damage. Australia’s Therapeutic Goods Administration withdrew the drug, while New Zealand regulators withdrew the 200- and 400-mg tablets. Canadian authorities have announced plans to review the drug’s safety.

At the FDA’s request, Novartis submitted clinical data on the liver profile of the proposed 100-mg dose studied over 12 months of therapy. The results showed 0.85 percent of patients had elevations of the liver enzymes aspartate aminotransferase and alanine aminotransferase of greater than three times the upper limit of normal, which is similar to levels observed with currently available NSAIDs, the company said. There were no cases of jaundice or hepatic failure on Prexige 100 mg in the clinical development program.