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FDA rejects Prexige osteoarthritis application


The FDA has rejected an application to approve the pain-relief medicine Prexige® (lumiracoxib) to treat osteoarthritis, it has emerged.

The Swiss pharmaceutical company Novartis, which makes the drug, said it will continue discussions with the regulator after the latest rebuff.

And it reiterated its belief that clinical trials show Prexige has fewer side-effects than other treatments.

Novartis was forced to remove the drug from the Australian market back in August after two patients died, and two others had to undergo liver transplants.

Prexige is currently sold in more than 50 countries, and sales of the drug reached $52m in the first half of this year, the company added.

Dr James Shannon, global head of development at Novartis, said: “Many patients cannot tolerate the gastrointestinal side-effects associated with NSAID pain treatments, such as those suffering from ulcers or who are being treated with anticoagulants like warfarin.

“We believe Prexige remains an important therapy for appropriate patients with osteoarthritic pain, and we will continue discussions with the FDA.”

In its response, the FDA said it remains open to exploring the use of the medicine in patients where Prexige will provide an acceptable benefit-to-risk balance.

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