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Ascendis Pharma (ASND) said the US Food and Drug Administration (FDA) identified deficiencies in the company’s new drug application (NDA) seeking approval of TransCon PTH (palopegteriparatide) in hypoparathyroidism.
The FDA informed the company that the deficiencies in the NDA, at this time time, prevents them from having further discussion of labeling and post-marketing requirements/commitments.
The deficiencies were not disclosed in the letter, according to the company.
The FDA noted that this does not reflect its final regulatory decision on the application, Ascendis noted.
In October 2022, the FDA granted priority review to the NDA, with a decision expected on April 30.
“This development one month from the agency’s PDUFA action date may cause a delay in the FDA’s final regulatory decision on the TransCon PTH NDA,” Ascendis President and CEO Jan Mikkelsen said.
The company noted that a European Commission decision is still ongoing for TransCon PTH during the fourth quarter of 2023. If approved, Ascendis expects its first launch in a European country in early 2024.
Hypoparathyroidism is a rare condition in which the body produces low levels of parathyroid hormone (PTH).
ASND -34.71% to $70 before marketing on April 3
