Benzinga | Jan 13, 2022 11:47AM EST

Ascendis Pharma Reports Received European Approval For TransCon Somatropin For Pediatric Growth Hormone Deficiency

Ascendis Pharma A/S (NASDAQ:ASND) today 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.

"We aim to build a leading global brand for TransCon hGH and are proud to have the first once-weekly growth hormone replacement for pediatric GHD approved in both the European Union and the United States," said Jan Mikkelsen, Ascendis Pharma President and CEO. "With this approval as a starting point, we look forward to bringing a broad portfolio of TransCon products to physicians and patients in Europe."

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.