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Ascendis获得FDA批准用于治疗生长激素缺乏症

2025-07-29 00:09

  • The U.S. FDA has approved Ascendis Pharma's (ASND) Skytrofa (lonapegsomatropin) as a once-weekly treatment for adults with growth hormone deficiency (GHD).
  • Skytrofa, which acts as a replacement of endogenous growth hormone, was previously approved by the agency in 2021 as a pediatric GHD therapy.  
  • Approval was based on the results of a phase 3 trial that compared the efficacy of weekly Skytrofa, also known as TransCon hGH, with daily somatropin weekly placebo and  in adults with GHD.

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