Ascendis Pharma Receives Positive CHMP Opinion for TransCon™ PTH (palopegteriparatide) for Adults with Chronic Hypoparathyroidism
17 Sep 2023
Phase 3Drug Approval
- Final European Commission decision expected within 67 days after positive opinion;
if approved, first European Union launch planned in Germany in early 2024
Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended the approval of TransCon PTH (palopegteriparatide) as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. The European Commission’s final decision on the Company’s Marketing Authorisation Application is expected within 67 days after the positive opinion. TransCon PTH is a prodrug of parathyroid hormone (PTH [1-34]) administered once daily.
“We are pleased to have received this positive CHMP opinion for TransCon PTH and look forward to the final European Commission decision,” said Birgitte Volck, M.D., Ph.D., Executive Vice President, Head of Clinical Development & Medical Affairs, Endocrinology Rare Diseases at Ascendis Pharma. “Hypoparathyroidism is the last endocrine deficiency for which replacement of the missing hormone is not widely available. Based on our clinical and patient-reported data and a robust supply chain, we are confident in our ability to address the hypoparathyroidism community’s urgent need for new treatment options to safely and effectively address the burden of their disease.”
CHMP adopted its positive opinion following its review of the totality of the Company’s clinical package for TransCon PTH (palopegteriparatide), which included data from the global Phase 3 PaTHway and Phase 2 PaTH Forward trials in adult patients with hypoparathyroidism, both of which used the same drug/device combination product that Ascendis plans to make available as its commercial product, if approved. Ascendis plans its first European Union launch of TransCon PTH (palopegteriparatide), if approved, in Germany in early 2024.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Germany (Heidelberg, Berlin and Munich) and the United States (Palo Alto and Redwood City, California, and Princeton, New Jersey). Please visit ascendispharma.com to learn more.
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