Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism
May 14, 2024
We would like to Thank You for your patience. Here is a statement from Ascendis.
An extension to August 14 is not the news that you wanted to hear today, but it is not bad news. It simply means the FDA needs more time to review our application.
The “major amendment” you read about in today’s press release is not a reflection of drug safety or efficacy. It simply reflects the FDA’s determination that information we submitted to them during the normal back-and-forth process (which takes place during every NDA review) requires more time to fully review.
We want to reassure you that there are no new safety or efficacy concerns with the drug, and we will continue everything as usual with the clinical trial patients and EAP patients. The EAP remains open for enrollment of new eligible patients, and new physicians can enroll in the program.
All of us at Ascendis understand the burden of your disease, and we understand that delays can cause additional stress. We are committed to following the process through. We remain confident that TransCon PTH could, if approved by the FDA, become an important new treatment option for adults with hypoparathyroidism living in the United States.
We are here to help. You or your physician can reach out to our Medical Affairs team at [email protected] with any questions you may have.
Back to News