FDA approves long-acting once-weekly treatment for pediatric growth hormone deficiency
The U.S. Food and Drug Administration has approved somatrogon-ghla (Ngenla; Pfizer), a once-weekly, human growth hormone analog indicated for the treatment of pediatric patients aged ≥3 years who have growth failure due to inadequate secretion of endogenous growth hormone.
It is expected to become available for U.S. prescribing in August 2023.
The FDA approval is based on data from a comprehensive Phase 3 study that evaluated the safety and efficacy of somatrogon-ghla administered once-weekly compared to the traditional once-daily somatropin treatment. Somatrogon-ghla demonstrated non-inferiority to somatropin, as measured by annual height velocity at 12 months, successfully meeting the primary endpoint of the study. The treatment was generally well tolerated, with a safety profile similar to somatropin.
Read the full press release here.