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Ascendis Pharma: FDA Issues CRL For TransCon PTH New Drug Application

May 01, 2023 — 07:23 am EDT

Written by RTTNews.com for RTTNews ->

(RTTNews) - Ascendis Pharma A/S (ASND) announced the FDA has issued a complete response letter for the TransCon PTH New Drug Application for the treatment of adults with hypoparathyroidism. The FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product. Ascendis will request a Type A meeting with the FDA.

The company noted that no new preclinical studies, or Phase 3 clinical trials to evaluate safety or efficacy, were requested in the letter.

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