In July 2022, Patient Worthy reported on data from the Phase 3 REAL 4 clinical trial. During the trial, researchers compared the safety, efficacy, and tolerability of Sogroya (somapacitan-beco) and Norditropin (somatropin) in pediatric patients aged 2.5 to 11 with growth hormone deficiency (GHD). Altogether, 200 patients who had never before received treatment enrolled in the study. Now, shares an article in EMPR, the FDA has expanded approval from solely adults. Sogroya is now approved to treat pediatric GHD in children aged 2.5 or older who lack endogenous growth hormone.
Sogroya is a human growth hormone analog that is administered once weekly via subcutaneous injection. While relatively safe and well-tolerated, Sogroya may have certain side effects. These include headache, fever, injection site reactions, pain in the extremities, and the common cold. Learn more about Sogroya here.
Additional data from the study helped inform this approval decision. Sogroya treatment helped to increase height and growth. Annualized height velocity was 11.2cm per year while taking this treatment.
About Pediatric Growth Hormone Deficiency (GHD)
Pediatric growth hormone deficiency (GHD) is a rare childhood disorder in which the anterior pituitary gland doesn’t create enough growth hormone. Growth hormone increases other hormones and proteins in the blood. This helps to reinforce growth plates and increase bone length. So growth hormone, as its name suggests, helps you to grow! But when your body doesn’t make enough of this hormone, it causes abnormally short height. Congenital GHD is caused by structural brain defects or genetic mutations; GH1, GHRH, PROP1, and POU1F1 have all been implicated. Brain trauma, radiation therapy, brain tumors, or infection may also cause pediatric GHD. However, in some cases, doctors cannot find a cause. Symptoms may include:
- A small penis (in male newborns)
- Low blood sugar (in newborns)
- Fatigue or lethargy
- A “chubby” build
- Stunted growth and a short stature
- An immature appearance compared to peers
- Fine hair and poor nail growth
- High-pitched voice
- Slow tooth eruption
- Impaired cardiac function