Panel backs refractory gout drug.(NEWS FROM THE FDA)

An FDA Arthritis Advisory Committee voted 14 to 1 to recommend the approval of pegloticase for management of refractory chronic gout. Several rheumatologists on the panel commented on the drug's unique ability to reduce tophi in patients in clinical trials.

Savient Pharmaceuticals Inc. has proposed that pegloticase, at a dose of 8 mg administered intravenously every 2 weeks, be approved for patients with refractory gout to control hyperuricemia and lessen the signs and symptoms of gout. Pegloticase--a recombinant formulation of porcine uricase, an enzyme not produced by humans--lowers serum uric acid by metabolizing urate into soluble allantoin that is excreted by the kidneys.

The panel's recommendation for approval came with a recommendation to monitor outstanding safety issues, including cardiovascular risk, in a post-marketing patient registry or long-term studies.

If approved, pegloticase would be marketed as Krystexxa. The FDA usually follows the recommendations of its advisory panels, which are not binding.

The FDA has granted orphan drug status to pegloticase because there are an estimated 100,000 people with refractory gout in the United States. Several panelists pointed out that the population of treatment-refractory patients has decreased since the approval of another urate-lowering therapy, febuxostat, in February.

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