Savient to Host Conference Call and Webcast on Wednesday, June 17 at 8:30 a.m. Eastern Time
EAST BRUNSWICK, N.J., June 16 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced today that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a vote of 14 to 1 that KRYSTEXXA(TM) (pegloticase), 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.
"We are very pleased with the Advisory Committee's recommendation, which supports our belief that KRYSTEXXA has a favorable risk to benefit profile in patients suffering from TFG," said Paul Hamelin, President of Savient Pharmaceuticals, Inc. "KRYSTEXXA has the potential to provide an important new treatment option for patients with TFG, who currently have no other available treatment options, and many of whom suffer from serious pain and disability."
The Advisory Committee's recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application that Savient has submitted for KRYSTEXXA.
Conference Call Information
Savient will host a live webcast to discuss the results from the FDA Advisory Committee meeting on June 17, 2009 at 8:30 a.m. Eastern Time.
|SOURCE Savient Pharmaceuticals, Inc.|
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