FDA Posts Briefing Materials For Advisory Committee Meeting Reviewing Natpara For Hypoparathyroidism

NPS Pharmaceuticals, Inc.

, a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has posted briefing materials for the September 12 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the company's Biologics License Application (BLA) for Natpara(R) (rhPTH[1-84]). Natpara is a bioengineered replacement therapy for endogenous parathyroid hormone (PTH) that NPS Pharma has developed for the treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of PTH. The briefing materials can be found on the FDA website at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm386727.htm. EMDAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders and makes appropriate recommendations to the FDA. The committee's recommendation will be considered by the FDA in its review of the company's BLA for Natpara. The Prescription Drug User Fee Act (PDUFA) date for completion of the review of the Natpara BLA is October 24, 2014.