NPS Pharmaceuticals, Inc. Expects to File Natpara™ BLA in Mid-2013
Published: Sep 05, 2012
BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that it expects to submit its Biologic License Application (BLA) for Natpara™ (recombinant human parathyroid hormone (rhPTH [1-84])) in mid-2013. The change in the company’s forecasted timeline is due to a request from the Medical Device Division of the U.S. Food and Drug Administration (FDA) to modify the company’s instructions for using the injection pen device to deliver Natpara. The FDA has not requested any new clinical data or clinical studies of Natpara. The requested changes will require the company to repeat its Usability Testing of the injection pen device using the modified instructions before submitting its BLA.