NPS Pharma: EMA Initiates Review Of MAA For Natpar - Quick Facts

(RTTNews) - NPS Pharmaceuticals Inc. (NPSP) announced the European Medicines Agency has validated and initiated its review of the company's marketing authorization application for Natpar (parathyroid hormone (rDNA)) for the treatment of Hypoparathyroidism, an endocrine disorder characterized by insufficient levels of parathyroid hormone. The EMA granted orphan drug designation for Natpar for the treatment of Hypoparathyroidism in January 2014.

The MAA includes results from 13 pharmacology studies and four company-sponsored efficacy and safety studies. The pivotal Phase 3 study, known as REPLACE, was a multinational, randomized, double-blind, placebo controlled study and the largest clinical trial conducted to date in Hypoparathyroidism.