Biopharmaceutical company NPS Pharmaceuticals Inc. (NPSP) announced that the U.S. Food and Drug Administration (FDA) has approved Natpara (parathyroid hormone) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
Natpara, a bioengineered replica of human PTH, is expected to be available in the second quarter of 2015.
The FDA approval of Natpara was supported by 12 pharmacology studies and four company-sponsored efficacy and safety studies. The pivotal Phase 3 study, known as REPLACE, was a randomized, double-blind, placebo-controlled study and the largest clinical trial conducted to date in patients with hypoparathyroidism.
Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone.
Hypoparathyroidism is a rare endocrine disorder in which the parathyroid glands fail to produce sufficient amounts of parathyroid hormone (PTH) or where the hormone lacks biologic activity.
In Europe, the European Medicines Agency (EMA) has validated and initiated its review of NPS Pharma's marketing authorization application for Natpar.
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