Pharma Focus Europe

Ascendis Pharma Granted Positive CHMP Opinion for TransCon™ PTH (palopegteriparatide) in Chronic Hypoparathyroidism Treatment for Adults

Friday, September 15, 2023

Ascendis Pharma A/S (Nasdaq: ASND) made an announcement today regarding a favorable development. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion and recommended approval for TransCon PTH (palopegteriparatide) for the treatment of chronic hypoparathyroidism in adults. The European Commission is expected to reach its final decision on the Marketing Authorisation Application within 67 days following this positive opinion. TransCon PTH is a prodrug of parathyroid hormone (PTH [1-34]) that is administered once daily.

Dr. Birgitte Volck, Executive Vice President and Head of Clinical Development & Medical Affairs, Endocrinology Rare Diseases at Ascendis Pharma, expressed satisfaction with the CHMP's positive opinion and expressed anticipation for the final decision from the European Commission. Dr. Volck emphasized the importance of addressing the unmet need for hypoparathyroidism treatment options and the company's confidence in the safety and efficacy of TransCon PTH based on clinical data and a reliable supply chain.

The CHMP's positive opinion was the result of a thorough review of Ascendis Pharma's complete clinical package for TransCon PTH, which included data from the global Phase 3 PaTHway and Phase 2 PaTH Forward trials involving adult patients with hypoparathyroidism. These trials utilized the same drug/device combination product that Ascendis Pharma intends to launch in the European Union, starting with Germany in early 2024, pending approval.

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