FDA panel backs NPS's Natpara for hypoparathyroidism

FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 8-5 to recommend approval of Natpara from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) to treat hypoparathyroidism. The PDUFA date is October 24.

There are currently no drugs approved for hypoparathyroidism. The standard of care is calcium and vitamin D. In briefing documents released ahead of Friday's EMDAC meeting, FDA reviewers concluded that once-daily subcutaneous injections of Natpara reduced the need for calcium and vitamin D supplements in patients with the condition (see BioCentury Extra, Sept. 10). ...