Ascendis Pharma's Growth Hormone Deficiency Med Scores European Approval

Ascendis Pharma's Growth Hormone Deficiency Med Scores European Approval

The European Commission (EC) has granted marketing authorization to Ascendis Pharma A/S's ASND Lonapegsomatropin (developed under the name TransCon hGH).

  • The approval for TransCon covers a once-weekly subcutaneous injection for children and adolescents ages 3 to 18 years with growth failure due to growth hormone deficiency (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 from the Company's Phase 3 heiGHt, fliGHt, and enliGHten Trials, which collectively treated more than 300 pediatric patients.
  • In August 2021, the FDA approved TransCon hGH to treat pediatric patients one year and older who weigh at least 11.5 kg.
  • Price Action: ASND shares are up 0.80% at $122.83 during the market session on the last check Thursday.

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