NPS Pharmaceuticals receives FDA approvable letter for Preos

By Lisa Kerner

Erie, Pa., March 10 - NPS Pharmaceuticals, Inc. said the Food and Drug Administration determined that the company's New Drug Application for Preos (recombinant human parathyroid hormone for injection) is approvable.

While NPS said its pivotal study with Preos demonstrated fracture risk reductions in postmenopausal women with osteoporosis, the FDA noted the higher incidence of hypercalcemia with Preos compared to a placebo and has requested additional clinical information.

The pivotal, multicenter, randomized, double-blind and placebo-controlled phase 3 clinical trial was designed to evaluate the potential of parathyroid hormone to reduce the risk of first and subsequent vertebral fractures in post-menopausal women, according to a company news release.

Additionally, the FDA requested information about the reliability and use of the injection device for delivery of the drug.

NPS said it plans to meet with the FDA to address the agency's concerns and to determine if additional studies are required. The company did not have a timeline for the approval or launch of Preos.

The company said it used results from the phase 3 study as the foundation of its E.U. and U.S. marketing authorization applications.

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 is located in Salt Lake City, Utah.

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