FDA Pushes Review Date For Ascendis Pharma's Hormone Disorder Candidate By Three Months

Tuesday, Ascendis Pharma A/S ASND announced that the FDA extended the review date for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism.

Hypoparathyroidism is an uncommon condition in which the body produces abnormally low levels of parathyroid hormone (PTH). 

The low production of PTH in hypoparathyroidism leads to abnormally low calcium levels in the blood and an increase of phosphorus in the blood.

The agency said the information Ascendis Pharma submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH constituted a major amendment to the NDA. 

Accordingly, the FDA has extended the PDUFA target action date by three months to August 14, 2024, from May 14 to provide time for a full submission review.

“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 CEO.

Also Read: Ascendis Pharma’s Growth Hormone Deficiency Candidate Outperforms in Phase 3 Trial.

The company said adults with hypoparathyroidism in the United States, who are receiving TransCon PTH in clinical trials and Expanded Access Program will continue to receive their medication, and the EAP remains open for enrollment for eligible patients. 

Last year, the FDA notified deficiencies in Ascendis Pharma’s marketing application for TransCon PTH (palopegteriparatide) in hypoparathyroidism. 

Monday, the company announced 2-year results from a post-hoc analysis of the Phase 3 PaTHway Trial demonstrating significant and sustained improvements in renal function in adults with chronic hypoparathyroidism treated with TransCon PTH. 

The treatment has already been approved in Europe and Britain and is marketed under Yorvipath. The company reported first-quarter sales of 1.5 million euros for the first two months since its launch.

Price Action: ASND shares were up 0.94% at $125.99 at the last check on Wednesday.