Posted by Michael Wonder on 05 Sep 2020
Ascendis Pharma announces U.S. FDA accepts biologics license application for TransCon hGH for paediatric growth hormone deficiency
4 September 2020 - Prescription Drug User Fee Act target action date of 25 June 2021.
Ascendis Pharma today announced that the FDA has accepted the company’s biologics license application for TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin (human growth hormone or hGH) for the treatment for paediatric growth hormone deficiency.
The FDA also has indicated that it is currently not planning to hold an advisory committee meeting to discuss the application at this time.
