EAST BRUNSWICK, N.J., Jan. 28 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that its biologics license application (BLA) for pegloticase for treatment-failure gout will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) on March 5, 2009 as required for a drug of a new therapeutic class.
Savient submitted its BLA to the FDA on October 31, 2008 seeking approval to market pegloticase in the United States. On December 29, 2008, the FDA accepted the BLA filing for review and granted priority review. A priority review is an FDA designation that is assigned to products that if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under priority review, the target date for an FDA decision on the pegloticase BLA is April 30, 2009.
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 two replicate six-month Phase 3 clinical trials for pegloticase were performed under the auspices of a Special Protocol Assessment (SPA) (2006). Pegloticase was granted orphan drug designation by the FDA in 2001.
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals, Inc. 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 enrollment was completed in March 2007; and t
|SOURCE Savient Pharmaceuticals, Inc.|
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