Ascendis Pharma A/S announced that the European Commission (EC) has granted marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the name TransCon hGH) as a once-weekly subcutaneous injection for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD). TransCon hGH is a prodrug of somatropin that provides sustained release of unmodified somatropin (hGH) at predictable therapeutic levels in the body. The EC approval is based on clinical results submitted in the Marketing Authorisation Application (MAA), including data from the Company's Phase 3 heiGHt, fliGHt and enliGHten Trials, which collectively treated more than 300 pediatric patients diagnosed with GHD, as well as data from a non-clinical safety program.

In August 2021, the U.S. Food & Drug Administration approved TransCon hGH for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone. TransCon hGH is also in development for pediatric GHD in Japan and China. Pediatric GHD is a serious orphan disease caused when the pituitary gland does not produce enough growth hormone.

Physiological levels of growth hormone are required for overall endocrine health and development of healthy bone, muscle, and adipose tissue. Children with GHD are characterized by short stature and may also experience metabolic abnormalities, psychosocial challenges, and an overall poor quality of life. For decades, the standard of care for GHD has been a daily subcutaneous injection of somatropin to improve growth and overall endocrine health.