Ascendis Pharma Reports the US FDA’s Acceptance of NDA for Priority Review of TransCon PTH to Treat Hypoparathyroidism in Adult Patients
Shots:
- The US FDA has accepted the NDA of TransCon PTH (palopegteriparatide) for Priority Review in adult patients with hypoparathyroidism. The PDUFA date is expected on April 30, 2023
- The company is currently planning to submit an MAA for TransCon PTH to the EMA for hypoparathyroidism in Q4’22 & the results from the P-III (PaTHway) of TransCon PTH in adult Japanese patients are also expected in Q4’22
- TransCon PTH is an investigational prodrug & is designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24hrs. for hypoparathyroidism. The company is expected to make TransCon PTH available shortly
Ref: Globenewswire | Image: Ascendis Pharma
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