- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending conditional approval of Shire plc's (NASDAQ:SHPG) Natpar (rhPTH[1-84]), a recombinant human protein with the full-length 84-amino acid sequence of endogenous parathyroid hormone (PTH), for the adjunctive treatment of adults with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
- Hypoparathyroidism, an Orphan Disease in the EU, occurs when inadequate levels of PTH are secreted by the parathyroid glands. It is characterized by low blood calcium (hypocalcemia) and high blood phosphate (hyperphosphatemia).
- Natpar is marketed in the U.S. as Natpara.
- Shares are off 1% premarket on light volume.