FDA review panel recommends approval of PTH therapy for hypoparathyroidism

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The drug, which was previously approved for osteoporosis treatment in Europe from 2006 to 2013, met the primary endpoints of decreased need for vitamin D and calcium in patients with hypoparathyroidism, as was shown by the manufacturer in their pivotal trial.

“A once-a-day injection provided a sustained increase in serum calcium lasting 24 hours, a decrease in urinary calcium excretion for 12 to 16 hours, the conversion of vitamin D to active vitamin D and a decrease in serum phosphate,” Hjalmar Lagast, MD, of NPS Pharmaceuticals, the drug sponsor and manufacturer, said during his presentation.

http://www.healio.com/endocrinology...pproval-of-pth-therapy-for-hypoparathyroidism
 
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