Boston, MA 09/11/2014 (wallstreetpr) – Biopharmaceutical company focused on delivering therapies, NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) disclosed that the Food and Drug Administration in the U.S. would decide its Biologics License Application or BLA for Natpara on September 12.
Committee To Decide
The company said that the regulator has posted briefing materials for the Endocrinologic and Metabolic Drugs Advisory Committee or EMDAC meeting scheduled for Friday, according to the company’s statement. The committee would review its BLA for Natpara and decide whether it can be approved or not.
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) said that MDAC would review the available data and evaluate the effectiveness and safety of investigational and marketed human drug products to be used for endocrine and metabolic disorders treatment. The committee would then recommend its opinion or actions to the FDA. The medical regulator would review the recommendations of the committee and decide the outcome of the company’s BLA for Natpara. NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) indicated that the Prescription Drug User Fee Act date for completing the review of Natpara BLA was fixed for October 24.
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) said that it has developed Natpara as a bioengineering replacement treatment for endogenous parathyroid hormone or PTH for treating Hypoparathyroidism, which was termed as a rare endocrine disorder differentiated by deficiency in the PTH levels.
Preliminary Review Results
The preliminary review done by the FDA was positive for NPS Pharmaceuticals, Inc. (NASDAQ:NPSP). Its drug candidate, Natpara, has reduced vitamin D supplements and Calcium in clinical trials, Reuters reported. However, data from one trial was not taken into consideration due to violations in manufacturing, the report said quoting FDA’s preliminary review.
The reviewers said that there was a similarity of some serious adverse events between the placebo group and the treatment group. The FDA has posted its review report on its website, just two days ahead of its MDAC meeting. The report said that Natpara drug was effective and that there was no significant safety imbalance.
