FDA extends review of Ascendis Pharma's hormone disorder therapy (updated)

Ascendis Pharma A/S

14/05/2024 19:47

(Adds details on FDA response in paragraph 2, details in
paragraphs 3 to 4)
       May 14 (Reuters) - The U.S. Food & Drug Administration
has extended its review of Ascendis Pharma's  A71.F  therapy to
treat adult patients with a hormone disorder by three months,
the company said on Tuesday.
    The health regulator notified that data submitted for the
ongoing review of the therapy, called TransCon PTH, constituted
"a major amendment" to the company's application seeking market
approval. 
        Last year, the FDA declined to approve the experimental
therapy, citing concerns linked to manufacturing controls of the
drug and device combination.
        The FDA, however, did not express any concerns about the
clinical data submitted  at that time and did not seek fresh
pre-clinical or late-stage trials in its so-called complete
response letter.
    The FDA is now set to make its decision known by Aug. 14.

 (Reporting by Sriparna Roy and Sneha S K in Bengaluru; Editing
by Krishna Chandra Eluri and Shailesh Kuber)
 ((Sriparna.Roy@thomsonreuters.com;))