FDA Expands Skytrofa Approval to Adults with Growth Hormone Deficiency: Clinical and Practice Implications
Highlight
– The FDA has approved lonapegsomatropin-tcgd (Skytrofa) for adults with growth hormone deficiency (GHD), expanding its original pediatric indication.
– In the phase 3 foresiGHt trial, once-weekly lonapegsomatropin was superior to placebo and comparable to daily somatropin in improving body composition, with similar safety outcomes.
– Skytrofa’s weekly regimen addresses a significant unmet need for treatment convenience and may enhance adherence among adult GHD patients.
– The approval is expected to influence clinical practice and prompt updates to adult GHD management guidelines.
Background
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This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.