24 October 2014 - 24 October 2014 - US-based rare diseases treatments developer NPS Pharmaceuticals (NASDAQ:NPSP) reported Thursday that the US FDA had extended the Prescription Drug User Fee Act (PDUFA) action date for the company's Natpara Biologics License Application (BLA) by three months from October 24, 2014 to January 24, 2015.

The extension was made to provide time for a full review of a major amendment. Extensions like this one are provided for by regulation. Furthermore, the FDA requested that NPS Pharma submit a Risk Evaluation and Mitigation Strategy (REMS) for Natpara. The company is working to finalise the REMS in advance of the revised PDUFA action date. So far, the FDA has not requested that additional clinical trials be completed before approval of Natpara. Still, the company expects a post-approval study commitment.

Natpara is a bioengineered replacement therapy for endogenous parathyroid hormone (PTH) which NPS Pharma has developed for the treatment of Hypoparathyroidism - a rare endocrine disorder characterised by insufficient levels of PTH.

NPS Pharma's president and CEO, Francois Nader, said that the company continues to advance its commercial readiness activities and is planning for the launch of Natpara in the second quarter of next year.