NPS Pharma Says FDA Advisory Committee To Review Natpara BLA - Quick Facts

(RTTNews) - NPS Pharmaceuticals Inc. (NPSP) said Friday that the U.S. Food and Drug Administration's or FDA Endocrinologic and Metabolic Drugs Advisory Committee or EMDAC is meeting today to review the company's Biologics License Application or BLA for Natpara (rhPTH [1-84]).

The Advisory Committee meeting is scheduled for 8:00 a.m. EDT and is scheduled to end at 5:00 p.m EDT.

Natpara is a bioengineered replacement therapy for endogenous parathyroid hormone or PTH that NPS Pharma has developed for the treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of PTH.

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.

Meanwhile, the company noted that Nasdaq has halted trading of the company's common stock.