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Ascendis Will Take On Daily Genotropin With Weekly Skytrofa

Company Will Try To Assert Superiority Claim

 
• By Joseph Haas

Ascendis’s growth hormone deficiency drug Skytrofa will offer a convenience advantage as a weekly injectable. But the label does not clearly delineate superiority shown in a Phase III trial.

FDA approved background, 3D rendering, blue street sign
Ascendis gets its first drug approval for weekly injectable growth hormone product

Ascendis Pharma A/S obtained its first product approval on 25 August with a US Food and Drug Administration thumbs-up for its weekly injectable formulation of somatropin in pediatric growth hormone deficiency. The Denmark-based firm offered few details about launch plans other than it anticipates introducing the product to the market during the fourth quarter and will seek “premium responsible pricing” in discussions with payers.

Analysts hailed the approval as an important validation for Ascendis’s TransCon (transient conjugation) controlled-release delivery technology

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