PreosTreatment for Osteoporosis
Preos New Drug Application Accepted for Review by FDA
SALT LAKE CITY, July 11, 2005 -- NPS Pharmaceuticals, Inc. announced today that as of July 9, 2005 the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) to market Preos (parathyroid hormone) for the treatment of osteoporosis in postmenopausal women. NPS submitted the application on May 10, 2005, and the FDA has now made a threshold determination that the Preos NDA is sufficiently complete to permit a substantive review.
Clinical results in the NDA are based upon data from 13 separate studies including an international multi-center Phase 3 trial of approximately 2,600 postmenopausal osteoporotic women who were randomized to receive either a daily subcutaneous injection of 100 micrograms of Preos or placebo, in addition to daily calcium and vitamin D supplements. The application also includes results from Phase 1 and Phase 2 studies with Preos, open-label extension studies following the pivotal Phase 3 trial, and combination studies evaluating the use of Preos with other drugs, as well as preclinical data and data related to manufacturing the product.
A similar application to market Preos in Europe under the brand name Preotact is currently under review by the European Medicines Agency.
About NPS Pharmaceuticals
NPS discovers, develops and commercializes small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company has drug candidates in various stages of clinical development backed by a strong discovery research effort.
Additional information is available on the NPS Pharmaceuticals.
Posted: July 2005
- NPS Updates Status of Preos NDA - March 29, 2006
- NPS Receives Approvable Letter for Preos NDA - March 10, 2006
- NPS Provides Update on Preos NDA Process and Timing - February 7, 2005
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