Posted by Michael Wonder on 28 Jun 2020
Ascendis Pharma announces submission of biologics license application to FDA for TransCon hGH in paediatric growth hormone deficiency
26 June 2020 - Ascendis Pharma today announced the submission of a biologics license application to the U.S. FDA for TransCon human growth hormone (lonapegsomatropin), a long-acting once-weekly pro-drug of somatropin (human growth hormone) for treatment for paediatric growth hormone deficiency.
Ascendis Pharma plans to submit a marketing authorisation application for TransCon human growth hormone to the European Medicines Agency in the third quarter, also for paediatric growth hormone deficiency.
Additionally, the company expects to initiate a phase 3 trial with TransCon hGH in paediatric human growth hormone in Japan in the fourth quarter, and a phase 3 trial is ongoing in Greater China through the company’s strategic investment in VISEN Pharmaceuticals.
