FDA Flags Deficiencies in Ascendis’ Hypoparathyroidism NDA
The FDA has identified undisclosed deficiencies in Ascendis Pharma’s new drug application (NDA) for TransCon PTH (palopegteriparatide) for treatment of hypoparathyroidism, an uncommon condition in which the body produces low levels of the parathyroid hormone.
In a letter to the company, the agency did not detail the deficiencies, but said they would preclude the agency from holding discussions with the company about labeling and postmarketing commitments, Ascendis said.
“Since the NDA deficiencies were not disclosed in the letter, we are eager to work with FDA” to address them, the company said.
The FDA granted the NDA a priority review in October 2022 and the agency’s decision date is still slated for April 30.