- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT - News) 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.
Tuesday, June 16, 2009
Savient Pharma gets Thumbs Up from FDA Panel
Savient (SVNT) got an overwhelming 14-1 approval from an FDA Panel today that reviewed their new gout drug named Krystexxa. This approval should alleviate most of the concern surrounding the feared side effects and allow for approval of the drug on 8/1/09. The stock was trading up some 25% in AH around $11.75.