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.
"We are very pleased with the Committee’s vote. Their recommendation reinforces our belief in the favorable benefit-risk profile of Natpara and its potential as a long-term treatment option for Hypoparathyroidism," said Francois Nader, MD, president and chief executive officer of NPS Pharma.
"As a bioengineered replacement therapy targeting the underlying cause of the disorder, Natpara has been shown in clinical studies to maintain serum calcium while demonstrating similar physiologic effects to the native parathyroid hormone. We look forward to working with the FDA to complete the final stages of review of our BLA for Natpara."
The Committee reviewed data from the Natpara clinical development program for Hypoparathyroidism, consisting of one pharmacology study and four 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 Hypoparathyroidism.
Natpara is a bioengineered replacement therapy for endogenous PTH that NPS Pharma has developed for the treatment of Hypoparathyroidism. The FDA has granted orphan drug status for Natpara for the treatment of Hypoparathyroidism. The European Medicines Agency has also granted orphan drug status for the drug under the trade name Natpar.