EC approval for Ascendis Pharma's TransCon hGH/Skytrofa

Danish biotech Ascendis Pharma (Nasdaq: ASND) saw its shares edge up more than 3% to $125.79 today, after it announced that the European Commission (EC) has granted marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the name TransCon hGH).

Also trade named Skytrofa, this is as a once-weekly subcutaneous injection for the treatment of children and adolescents ages three 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’s president and chief executive, adding: “With this approval as a starting point, we look forward to bringing a broad portfolio of TransCon products to physicians and patients in Europe.”