FDA rejects Novartis’ Cox-2 Inhibitor, Prexige

WASHINGTON The U.S. Food and Drug Administration announced that it has rejected Novartis’ once-daily treatment for pain caused by osteoarthritis, officials said Friday.

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

Though the FDA did not approve the use of the drug in the U.S., the organization said it would consider the use of Prexige for patients in whom the drug would provide an acceptable risk-benefit balance.

The drug is approved in more than 50 countries, Novartis said.

Recently, regulatory authorities of several nations have been questioning the safety of Prexige because of reports that patients consuming the drug had suffered from 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 medication, the company said.