On June 28, 2023, Pfizer and OPKO Health received U.S. Food and Drug Administration (FDA) approval of Ngenla® (somatrogon-ghla) for the replacement of endogenous growth hormone in children who have growth hormone deficiency (GHD) and who are aged three years and older. The recommended dose is 0.66 mg/kg administered as a once-weekly subcutaneous (SC) injection on the same day each week, with the injection site, rotated between the abdomen, thighs, buttocks, and upper arms. Ngenla, a long-acting human growth hormone analog, is expected to launch in August 2023. Full prescribing information can be found here.
At a Glance
- Brand (Generic) Name: Ngenla (somatrogon-ghla)
- Manufacturer: Pfizer and OPKO Health
- Date Approved: June 28, 2023
- Indication: treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone
- Dosage Forms Available: single-dose prefilled pens containing 24mg/1.2mL (20mg/mL) and 60mg/1.2mL (50mg/mL)
- Launch Date: August 2023
- Estimated Annual Cost: $99,600 for a child weighing 35kg
- GHD is a rare condition caused by a lack of growth hormone in the body, which can result in stunted growth. It affects about one out of every 4,000 to 10,000 children.
- Approval of Ngenla was based on a Phase III study that showed that both once-weekly Ngenla and once-daily somatropin produced similar results as measured by annual height velocity after one year.
- The FDA already has approved two other long-acting growth hormone analogs: Skytrofa® (lonapegsomatropin-tcgd) from Ascendis Pharma and Sogroya® (somapacitan-beco) from Novo Nordisk. Skytrofa was approved in October 2021 for use in pediatric patients as young as one year of age who have GHD. It was introduced to the U.S. market in March 2022. Sogroya was approved for adults in August 2020 and expanded to children as young as 30 months of age earlier this year. Sogroya is expected to launch in the near future.