PreosTreatment for Osteoporosis
NPS Receives Approvable Letter for Preos NDA
SALT LAKE CITY, March 10, 2006 -- NPS Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has determined that the company's new drug application (NDA) for Preos (parathyroid hormone [rDNA origin] for injection) is approvable. The FDA indicated that the company's pivotal study with Preos demonstrated significant fracture risk reductions in postmenopausal women with osteoporosis, but noted the higher incidence of hypercalcemia with Preos compared to placebo. The agency expressed concern regarding hypercalcemia associated with the proposed daily dose of Preos and has requested additional clinical information. The agency also requested additional information regarding the reliability and use of the injection device for delivery of the drug.
NPS has requested a meeting with the FDA to address these issues and to determine whether existing data are sufficient to respond to the agency's concerns or whether additional studies will be required. Subsequent to these discussions, NPS will be better able to project the timing for approval and launch of Preos.
Preos is recombinant human parathyroid hormone (PTH). NPS has studied Preos in a number of clinical settings to document its safety and effects on bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-center, randomized, double-blind and placebo-controlled clinical trial designed to evaluate the potential of PTH to reduce the risk of first and subsequent vertebral fractures in post-menopausal women.
In the TOP study, Preos demonstrated a statistically significant reduction in the risk of new vertebral fractures in women with and without pre-existing osteoporosis-related fractures. Results from the TOP study have been the foundation of both the E.U. and the U.S. marketing authorization applications.
Source: NPS Pharmaceuticals
Posted: March 2006
- NPS Updates Status of Preos NDA - March 29, 2006
- Preos New Drug Application Accepted for Review by FDA - July 11, 2005
- NPS Provides Update on Preos NDA Process and Timing - February 7, 2005