FDA Approves NPS Pharma’s Natpara for Hypoparathyroidism
NPS Pharma plans to make Natpara available for some patients with hypoparathyroidism in the second quarter of this year, following FDA approval last week.
Shire says the approval “further validates” its decision to acquire the rare disease treatment manufacturer for $5.2 billion. The deal is expected to close by March 30.
Natpara (parathyroid hormone) is indicated for patients whose calcium levels cannot be controlled using calcium and vitamin D supplements. NPS tested the drug in 124 patients in a Phase III study and found that 42 percent kept their blood calcium levels normal with both Natpara and reduced supplementation, compared with 3 percent of patients on placebo.
Approximately 20 percent to 40 percent of the 50,000 to 60,000 hypoparathyroidism patients in the U.S. still have trouble controlling calcium levels using calcium supplements and prescription vitamin D, estimates NPS Chief Medical Officer Roger Garceau.
The drug will only be available through a Risk Evaluation and Mitigation Strategy, as it carries a boxed warning for osteosarcoma found in rats. — Lena Freund