and as expected
PDUFA Action Date for Natpara® BLA Extended Three Months to January 24, 2015
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today reported that the U.S. Food and Drug Administration (FDA) has extended the company’s Prescription Drug User Fee Act (PDUFA) action date for its Natpara Biologics License Application (BLA) by three months from October 24, 2014 to January 24, 2015. The FDA extended the action date to provide time for a full review of a major amendment; such extensions are provided for by regulation. In addition, the FDA requested that NPS Pharma submit a Risk Evaluation and Mitigation Strategy (REMS) for Natpara and the company is working to finalize the REMS in advance of the revised PDUFA action date. To date, the FDA has not requested that additional clinical studies be completed prior to the approval of Natpara; however, the company expects a post-approval study commitment.
