FDA Panel Recommends Savient Pharmaceuticals (SVNT) Gout Treatment
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Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the Arthritis Advisory Committee appointed by the FDA recommended by a vote of 14 to 1 that KRYSTEXXA, a biologic PEGylated uricase enzyme, be granted marketing approval by the FDA for the treatment of refractory chronic gout.
Refractory chronic gout or treatment failure gout (TFG) is gout in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with conventional urate-lowering therapy at the maximum medically appropriate dose or for whom conventional urate-lowering therapy is contraindicated. The current target Prescription Drug User Fee (PDUFA) action date for the FDA's decision as to whether to grant marketing approval for KRYSTEXXA is August 1, 2009.
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