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

(RTTNews) - Ascendis Pharma A/S (ASND) said that the U.S. Food & Drug Administration has granted Orphan Drug exclusivity to YORVIPATH (palopegteriparatide, developed as TransCon PTH), providing seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in adults.

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

Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs and affects an estimated 70,000 to 90,000 people in the United States.

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

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