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Ascendis' Hypoparathyroidism Drug Scores FDA Approval As First and Only Treatment, Replacing Takeda's Drug Discontinued Due To Supply Issues

Monday, the FDA approved Ascendis Pharma A/S’ (NASDAQ:ASND) Yorvipath (palopegteriparatide; developed as TransCon PTH) for hypoparathyroidism in adults. Hypoparathyroidism is a rare, treatable condition that occurs when a person has low levels of parathyroid hormone in the blood. This causes low calcium levels (hypocalcemia) and high phosphorous levels. Also Read: Ascendis Pharma’s Growth Hormone Deficiency Candidate Outperforms in Phase 3 Trial. Hypoparathyroidism impacts multiple organs and affects an estimated 70,000 to 90,000 people in the U.S. 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. At launch, Ascendis plans to offer a suite of patient services for Yorvipath through its U.S. Ascendis Signature Access Program. The approval was based on the clinical package for TransCon PTH (palopegteriparatide) submitted ...