Dr Francois Nader, executive vice president and COO, said: “We greatly appreciate the FDA’s support of our efforts to evaluate the use of Preos as a hormone replacement therapy to treat hypoparathyroidism. The results of the proof-of-concept study using Preos in this indication have been very encouraging, especially when compared to current palliative therapies that often result in long-term toxicities and complications for patients.”
Orphan drug designation entitles NPS to a seven-year period of marketing exclusivity in the US for Preos, if it is approved by the FDA for the treatment of hypoparathyroidism. It also enables the company to apply for research funding, tax credits for certain research expenses, and a waiver from the FDA’s application user fee.