Ascendis Pharma A/S announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for TransCon hGH, marketed as SKYTROFA, for the treatment of adult growth hormone deficiency (GHD). This marks a crucial step towards expanding the product's label beyond pediatric GHD.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025, for its review of the sBLA. The submission is supported by data from the Phase 3 foresiGHt trial, which demonstrated the efficacy and safety of once-weekly TransCon hGH in adults with GHD.
In the foresiGHt trial, TransCon hGH showed superiority on its primary and key secondary efficacy endpoints at Week 38, including a statistically significant reduction in trunk fat and an increase in total body lean mass compared to placebo. The treatment was generally safe and well tolerated, with a safety profile comparable to daily human growth hormone treatment.
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