– Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to August 14, 2024
COPENHAGEN, Denmark, May 14, 2024 – Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months, to August 14, 2024, to provide time for a full review of the submission.
“We have responded to all requests received to date from FDA and will work with the agency as they continue their review of our NDA,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “Adults with hypoparathyroidism in the United States, who are receiving TransCon PTH in our clinical trials and our Expanded Access Program (EAP) will continue to receive their medication, and the EAP remains open for enrollment for eligible patients. We remain committed to bringing TransCon PTH to adults with hypoparathyroidism in the United States, who face an urgent need for new treatments.”
