Savient Pharmaceuticals, Inc.
Savient Resubmits Biologics License Application for KRYSTEXXA pegloticase for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy
Published in Medical Letter on the CDC and FDA, April 4th, 2010
Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) announced that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for KRYSTEXXA™ (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
The resubmission includes data from three consecutive manufacturing validation batches of the...
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