NPS Pharmaceuticals (NPSP) received encouraging news when the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended the approval of the company’s hormone replacement therapy Natpara (rhPTH [1-84]).

NPS Pharma’s candidate was recommended for long-term use to treat patients suffering from hypoparathyroidism, a rare disease caused by the deficiency/absence of parathyroid hormone, by 8 of the 13 panel members.

The positive opinion rendered by the panel was widely expected following the upbeat briefing materials released by the FDA prior to the panel meeting. NPS Pharmaceuticals’ (NPSP) stock price jumped over 25% when the FDA released upbeat briefing materials on the company’s pipeline candidate Natpara ahead of the review by its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). The FDA panel is scheduled to review the New Drug Application for Natpara, a hormone replacement therapy, on Sep 12, 2014.

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The favorable panel opinion was based on encouraging data from one pharmacology study in addition to four efficacy and safety studies on Natpara. The pivotal phase III randomized, double-blind, placebo controlled study (REPLACE) was the largest clinical trial conducted on hypoparathyroidism patients so far. The FDA panel’s positive opinion brightens the chances of Natpara gaining FDA approval next month (target date: Oct 24). The candidate enjoys orphan drug status in the U.S. as well as in the EU.

The current standard of care for treating the rare disease is oral calcium and active vitamin D. However, they fail to address the underlying deficiency of PTH and instead result in hypercalciuria, hyperphosphatemia and reduced bone turnover.

The briefing materials posted by the FDA stated that Natpara was an effective treatment for hypoparathyroidism. The document further stated that Natpara therapy results in the maintenance of serum calcium levels in the body and reduces the need for oral calcium and active vitamin D. The conclusions were drawn on the basis of data from clinical trials. Data from one trial site was not considered due to the occurrence of a problem.

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Natpara approval will augment the company’s top line and reduce its dependence on Gattex, currently NPS Pharma’s sole marketed product. Focus will also remain on the development of NPSP795 (autosomal dominant hypocalcemia: phase IIa).

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