The Food and Drug Administration (FDA) has approved Sogroya® (somapacitan-beco) for the treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH). Previously, the human growth hormone analog had only been approved for adult patients with GH deficiency.
Sogroya is administered by subcutaneous injection once weekly. Reversible binding to endogenous albumin delays elimination of somapacitan, thereby prolonging the half-life and duration of action of the treatment.
The expanded approval was based on data from the phase 3 REAL4 study (ClinicalTrials.gov Identifier: NCT03811535), which included 200 treatment-naïve, pediatric patients (2.5-11 years old) with GH deficiency. Study participants were randomly assigned to receive once-weekly somapacitan (n=132) or daily somatropin (n=68) for 52 weeks.
Annualized height velocity at week 52 (primary endpoint) was reported to be 11.2cm/year with once-weekly somapacitan and 11.7cm/year with daily somatropin (estimated treatment difference, -0.5; [95% CI, -1.1, 0.2]). The mean increase in height standard deviation score over the 52-week period was 1.25 and 1.30 in the once-weekly somapacitan and daily somatropin groups, respectively.
The most common adverse reactions reported in pediatric patients were nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reaction.
Sogroya is supplied as a liquid solution in a ready-to-use prefilled pen. The product is expected to be available for both pediatric and adult patients in the coming months.
- FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency. News release. Novo Nordisk. April 28, 2023. https://www.novonordisk-us.com/content/nncorp/us/en_us/media/news-archive/news-details.html?id=166098.
- Sogroya. Package insert. Novo Nordisk; 2023. Accessed April 28, 2023. https://www.novo-pi.com/sogroya.pdf.