EAST BRUNSWICK, N.J., Oct. 31 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced the submission of its BLA to the U.S. Food and Drug Administration (FDA) seeking approval to market pegloticase in the United States along with its request for a priority review. Savient's filing includes data from both the six-month placebo controlled Phase 3 pivotal trials, as well as data from the Open Label Extension (OLE) study. The data set includes 101 patients with at least twelve months continuous treatment.
"Filing the BLA for pegloticase is a major milestone for Savient," said Christopher Clement, President and Chief Executive Officer. "This filing reflects our commitment to changing the paradigm of therapy available to the treatment-failure gout population and brings us one step closer to commercializing this drug and offering a solution to patients who suffer from this debilitating disease."
The two replicate, six-month, Phase 3 clinical trials for pegloticase were performed under the auspices of a Special Protocol Assessment (SPA) and pegloticase was granted Orphan Drug designation by the FDA. The OLE study was established to allow patients who completed the Phase 3 program the opportunity to continue to receive pegloticase for an extended period of time.
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals is a biopharmaceutical company engaged in
developing and distributing pharmaceutical products that target unmet
medical needs in both niche and broader markets. The company's product
development candidate, pegloticase for treatment-failure gout, has reported
positive Phase 1, 2 and 3 clinical data. Patient dosing in the Phase 3
clinical studies began in June 2006; patient
|SOURCE Savient Pharmaceuticals, Inc.|
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