EAST BRUNSWICK, N.J., May 7 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that its biologics license application (BLA) for KRYSTEXXA(TM) (pegloticase), a novel biological drug for treatment failure gout (TFG) patients, will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) on June 16, 2009.
In December, the FDA accepted the Company's BLA for KRYSTEXXA and granted priority review status, which is a designation assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for a disease or condition for which there is no adequate therapy available.
In January, the Company submitted to the FDA several key amendments for the KRYSTEXXA BLA to further strengthen and clarify the overall BLA application. The FDA reviewed and accepted the amendments and determined that the additional information contained in the submissions constituted major amendments. In an effort to include the amendments as part of the review, the FDA elected to extend the BLA review period and assigned a revised PDUFA date of August 1, 2009.
ABOUT KRYSTEXXA(TM)
KRYSTEXXA(TM) (pegloticase) is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The two Phase 3 pivotal trials assessed the safety and efficacy of a six-month course of pegloticase therapy in patients with treatment failure gout, under the auspices of an SPA from the FDA. KRYSTEXXA was granted orphan drug indication by the FDA in 2001. Savient's KRYSTEXXA BLA filing includes data from both the six-month placebo-controlled Phase 3 pivotal trials, as well as data from the open label extension study.
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader specialty markets. Savient's product development candidate, KRYSTEXXA(TM) (pegloticase) for treatment failure gout has reported positive Phase 1, 2 and 3 clinical data. The KRYSTEXXA Phase 3 clinical studies were completed in October 2007; the BLA was filed with the FDA in October 2008 and the FDA granted priority review status in December 2008. The Company submitted amendments to the BLA to the FDA in January 2009 and the FDA extended the review period by three months, revising the PDUFA date to August 1, 2009.
