NPS Submits BLA for Natpara for Hypoparathyroidism
NPS Pharmaceuticals announced that it has submitted a Biologic License Application (BLA) to the FDA 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 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.
The primary endpoint was achieved in 53% of Natpara-treated patients by decreasing doses of oral calcium and active vitamin D by 50% or more, while maintaining serum calcium levels by the end of the treatment phase. In contrast, only 2% of the placebo group (P<0.001) met the primary endpoint.
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