FDA to Review Natpara BLA for Hypoparathyroidism
NPS Pharmaceuticals announced that the FDA has accepted for review its Biologics License Application (BLA) for Natpara (recombinant human parathyroid hormone 1-84, rhPTH[1-84]) for the treatment of hypoparathyroidism.
Natpara is a bioengineered replica of human parathyroid hormone (PTH) designed to replace the missing hormone.
The clinical development program for Natpara includes 12 pharmacology studies, five efficacy and safety studies in hypoparathyroidism, and a supporting development program consisting of seven studies in osteoporosis. The pivotal Phase 3 study known as REPLACE, was a randomized, double-blind, placebo controlled study of 134 patients with hypoparathyroidism.
Previously, the FDA granted Natpara Orphan Drug status for the treatment of hypoparathyroidism.For more information call 908-450-5300 or visit NPSP.com.