FDA accepts NDA for TransCon PTH to treat hypoparathyroidism
Ascendis Pharma announced that the FDA has accepted for Priority Review its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) in adult patients with hypoparathyroidism and has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2023
TransCon PTH is an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism. The FDA said that it is not currently planning to hold an advisory committee meeting to discuss the application.
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