The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 8 to 5 that the available data in support of approving of Natpara® for the long-term treatment of Hypoparathyroidism.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 8 to 5 that the available data in support of approving of Natpara® for the long-term treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH).
Natpara is a bioengineered replacement therapy for endogenous PTH developed by NPS Pharma. The FDA in addition to the European Medicines Agency has granted orphan drug status for Natpara for the treatment of Hypoparathyroidism. In the EU, the trade name for this drug is Natpar™.
EMDAC reviewed data from the Natpara clinical development program for Hypoparathyroidism, which consisted of one pharmacology study and four efficacy and safety studies. REPLACE, the pivotal Phase 3 study, was a randomized, double-blind, placebo controlled study and the largest clinical trial conducted to date in Hypoparathyroidism.
Francois Nader, MD, president and chief executive officer of NPS Pharma stated “We look forward to working with the FDA to complete the final stages of review of our BLA for Natpara.”
The Committee’s recommendation will be considered by the FDA in its review of the company’s Biologics License Application (BLA) for Natpara, which has a Prescription Drug User Fee Act (PDUFA) date of October 24, 2014. The FDA is is not obligated to follow its committee’s recommendation; however it normally does.
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