The once-weekly growth hormone analog somapacitan (Sogroya, Novo Nordisk) has been given the green light in both Europe and the United States for the treatment of children and adolescents with growth failure due to growth hormone deficiency.
On May 26, the European Medicine Agency's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the product for replacement of endogenous growth hormone in children aged 3 years and older.
That decision followed the US Food and Drug Administration's approval in April of the new indication for somapacitan injection in 5 mg, 10 mg, or 15 mg doses for children aged 2.5 years and older. The FDA approved the treatment for adults with growth hormone deficiency in September 2020.
Growth hormone deficiency is estimated to affect between 1 in 3500 to 1 in 10,000 children. If left untreated, the condition can lead to shortened stature, reduced bone mineral density, and delayed appearance of teeth.
The European and American regulatory decisions were based on data from the phase 3 multinational REAL4 trial, published in the Journal of Clinical Endocrinology & Metabolism at the end of last year, in 200 prepubertal children with growth hormone deficiency randomly assigned 2:1 to weekly subcutaneous somapacitan or daily somatropin. At 52 weeks, height velocity was 11.2 cm/year with the once-weekly drug compared with 11.7 cm/year with daily somatropin, a nonsignificant difference.
There were no major differences between the drugs in safety or tolerability. Adverse reactions in the REAL4 study that occurred in more than 5% of patients included nasopharyngitis, headache, pyrexia, extremity pain, and injection site reactions. A 3-year extension trial is ongoing.
The European Commission is expected to make a final decision in the coming months, and if approved somapacitan will be available in some European countries beginning in late 2023.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.
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Cite this: Once-Weekly Growth Hormone Somapacitan Approved for Kids - Medscape - Jun 05, 2023.