NPS Pharmaceuticals, a New Jersey-based biopharmaceutical company developing treatments for rare diseases, announces January 3, 2014, that the European Commission (EC) grants Orphan Drug Designation (ODD) to Natpara (Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the treatment of Hypoparathyroidism. Natpara is a bioengineered replacement for endogenous Parathyroid Hormone (PTH) – “a hormone replacement therapy for the underlying cause of Hypoparathyroidism”.
Hypoparathyroidism is the decreased function of the parathyroid glands resulting in the under production of PTH. PTH’s functions are :
• Modulation of serum calcium and phosphate
• Regulation of renal excretion of phosphate and calcium
• Activation of Vitamin D
• Maintenance of normal bone turnover.
Natpara Regulatory Activities
• In 2007, receives FDA ODD Designation
• In October 2013, submission of US Biologic License Application (BLA) to FDA
• In January 2014, receives EC ODD.
NPS Pharmaceuticals also makes orphan drug Gattex, an injectable treatment for rare disease Short Bowel Syndrome…
View original post 33 more words
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....
