FX.co ★ Ascendis Pharma Gets U.S. Orphan Drug Exclusivity For YORVIPATH In Adult Hypoparathyroidism

Ascendis Pharma A/S (ASND) announced that the U.S. Food and Drug Administration (FDA) has granted seven years of market exclusivity to YORVIPATH (palopegteriparatide, developed as TransCon PTH) under the Orphan Drug designation for the treatment of hypoparathyroidism in adults.

YORVIPATH, a prodrug of parathyroid hormone (PTH [1-34]), is administered once daily. It is designed to provide continuous exposure to released PTH over a 24-hour period.

Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, affecting an estimated 70,000 to 90,000 individuals in the United States.

TransCon PTH (palopegteriparatide) initially received Orphan Drug Designation from the U.S. FDA in June 2018.