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NPS BLA Accepted by FDA

Natpara action date October 2014 for hypoparathyroidism indication

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has accepted the BLA from NPS Pharmaceuticals for Natpara (recombinant human parathyroid hormone 1-84, (rhPTH[1-84])) for the treatment of hypoparathyroidism. Under the Prescription Drug User Fee Act (PDUFA), the goal date for a decision by the FDA is October 24, 2014.

Natpara is a bioengineered replacement for endogenous parathyroid hormone (PTH) that NPS has developed for the treatment of hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, a principal regulator of the body’s mineral homeostasis.

The company’s clinical development program for Natpara includes 12 pharmacology studies, five efficacy and safety studies in hypoparathyroidism, and a supporting development program consisting of seven studies in osteoporosis. The pivotal Phase III study known as REPLACE, was a randomized, double-blind, placebo controlled study of 134 patients with hypoparathyroidism. The FDA and EMA have each granted orphan drug status for Natpara for the treatment of hypoparathyroidism.

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