FDA Approves SKYTROFA for Adult Growth Hormone Deficiency

Growth hormone deficiency (GHD) in adults, a rare disorder characterized by decreased or absent endogenous growth hormone production, leads to abnormal body composition, dyslipidemia, insulin resistance, and increased risks of metabolic syndrome, cardiovascular disease, and impaired quality of life, including cognitive and psychological issues. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have shown promise in managing related comorbidities, but adherence to the standard daily somatropin injections remains a challenge. Ascendis Pharma A/S has developed SKYTROFA® (lonapegsomatropin-tcgd), a prodrug of somatropin administered weekly, previously approved by the U.S. Food & Drug Administration (FDA) in 2021 for pediatric GHD. This study evaluates its efficacy and safety for adult GHD.