Somapacitan (Sogroya, Novo Nordisk) injections are indicated to replace endogenous growth hormone in children with growth hormone deficiency.
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,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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