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November 8, 2023

New Drugs and Therapeutics Update – NGENLA

New Drugs and Therapeutics Update – NGENLA

By Dania Al-Hamad, MD, and Christine Yu, MD

 

NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog, was approved by the FDA in June 2023 for treatment of growth failure in pediatric patients aged three years and older with growth hormone deficiency (GHD). Approval was based on an open label multicenter randomized active-controlled non-inferiority study comparing once-weekly somatrogon 0.66 mg/kg/week to once daily somatropin 0.24 mg/kg/week in prepubertal children demonstrating similar 12-month height velocity and safety between the two growth hormone groups.   Once-weekly NGENLA is available in two prefilled disposable pens, 24 mg/1.2 mL (delivering somatrogon in 0.2 mg increments) and 60 mg/1.2 mL (delivering somatrogon in 0.5 mg increments) and can be administered any time of the day.

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