Savient Pharmaceuticals' resubmission of BLA for KRYSTEXXA accepted for FDA review

Mar 30 2010

Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application (BLA) for KRYSTEXXA™ (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy.

The FDA has deemed the resubmission a complete, class 2 response and has established September 14, 2010 as the PDUFA action date. The FDA also acknowledged that the BLA resubmission contains additional chemistry, manufacturing and controls (CMC), Safety Update, Labeling, Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide submitted in response to the FDA's July 31, 2009 complete response letter.  

"As expected, the FDA has determined our resubmission to be a class 2 review matter and thus the PDUFA action date is September 14th, 2010," stated Paul Hamelin, R.Ph., President of Savient.  "We look forward to working with the FDA in moving KRYSTEXXA through the regulatory review process over the next few months."