Ascendis Pharma’s TransCon hGH Receives EC’s Approval for Pediatric Growth Hormone Deficiency
Shots:
- The EC granted marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the name TransCon hGH) as a QW, SC injection to treat children and adolescents ages 3 to 18 yrs with GHD
- The approval is based on clinical results submitted in the MAA from the company’s P-III (heiGHt, fliGHt and enliGHten) trials, treating >300 pediatric patients diagnosed with GHD, along with the data from a non-clinical safety program
- The US FDA approved TransCon hGH in Aug 2021 for the treatment of pediatric patients 1 yr and older, weighing at least 11.5 kg and having growth failure due to insufficient secretion of endogenous growth hormone. Additionally, TransCon hGH is in development for pediatric GHD in Japan & China
Ref: Globe Newswire | Image: Ascendis
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