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Ascendis files BLA for growth hormone deficiency drug
October 2020
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COPENHAGEN, Denmark—Ascendis Pharma A/S, a biopharmaceutical company that uses its novel TransCon technologies to address unmet medical needs, recently announced that the FDA had accepted the company’s Biologics License Application (BLA) for TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin (human growth hormone or hGH) for the treatment for pediatric growth hormone deficiency (GHD).
 
“We look forward to engaging with the FDA during its review of our BLA submission for TransCon hGH in pediatric GHD,” said Dr. Dana Pizzuti, Ascendis Pharma’s senior vice president of development operations. “Based on data from our clinical development program, we believe once-weekly TransCon hGH has the potential to expand treatment options for clinicians and children with GHD.”
 
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.1 The BLA for pediatric GHD is supported by the results of a clinical development program that included eight clinical trials evaluating safety and efficacy in more than 400 subjects with GHD.

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