Novartis Says FDA Seeks More Data On Gout Drug Candidate ACZ885

Swiss drugmaker Novartis AG (NVS) Monday said the US Food and Drug Administration has sought additional information regarding the company's ACZ885, or canakinumab, in gouty arthritis patients.

In a Complete Response letter, as part of the regulatory review for ACZ885, the FDA sought more information, including clinical data to evaluate the benefit risk profile in refractory patients. Novartis said it would continue to work with the FDA on next steps.

On June 21, an advisory committee of the FDA voted in favor of the overall efficacy, but recommended that additional retreatment data would be needed to assess the overall safety profile of ACZ885.

Clinical trials had showed that gouty arthritis patients treated with ACZ885 at the time of an attack experienced superior pain relief at 72 hours and a significant reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide.

Gouty arthritis is an inflammatory disease affecting 1-4 percent of adults, causing severe pain and long-term consequences.

Based on these trials, Novartis submitted ACZ885 for regulatory review in the European Union in 2010 and in the U.S., Canada and Switzerland in the first quarter of 2011.

According to Novartis, ACZ885 was generally well tolerated in these studies, with most adverse events being mild to moderate in severity. However, adverse events were reported more frequently in patients treated with ACZ885 compared to those treated with triamcinolone acetonide.

The drug, expected to become a blockbuster, is already approved in an inflammatory disorder called Cryopyrin-Associated Periodic Syndromes.

Novartis said it remains committed to studying ACZ885 in inflammatory diseases where interleukin-1 beta plays a key role.

NVS closed Friday's regular trade on the NYSE at $56.59, compared to the prior close of $56.24, on 4.09 million shares.

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