8 September 2020 - Ascendis Pharma announced today the submission of a marketing authorisation application to the EMA seeking approval for TransCon hGH (lonapegsomatropin), an investigational long-acting once-weekly prodrug of somatropin, for the treatment of paediatric patients who are diagnosed with growth hormone deficiency.

TransCon hGH is designed to release somatropin with the same mode of action and distribution as once-daily somatropin products, but with a once-weekly injection. 

The marketing authorisation application submission includes data from the clinical development program for TransCon hGH that included eight clinical trials evaluating safety and efficacy in more than 400 subjects with growth hormone deficiency.

Read Ascendis Pharma press release