Ascendis Pharma Receives the EMA’s CHMP Positive Opinion of TransCon PTH (palopegteriparatide) for Chronic Hypoparathyroidism
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending the approval of TransCon PTH as a parathyroid hormone (PTH) replacement therapy for treating adults with chronic hypoparathyroidism. The EC’s final decision is expected within 67 days after the positive opinion
- The positive opinion was based on the results from the P-III trial (PaTHway) & P-II (PaTH Forward) trials in adult patients with hypoparathyroidism. Both used the same drug/device combination product as its commercial product for TransCon PTH
- If TransCon PTH is approved, the first European Union launch is planned in Germany in early 2024
Ref: Globenewswire | Image: Ascendis Pharma
Related News:- Ascendis Pharma Presented One-Year P-III Trial (PaTHway) Results of TransCon PTH for Hypoparathyroidism at ENDO 2023
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
