Somatrogon in paediatric growth hormone deficiency: a profile of its use in the EU

Abstract

Somatrogon (NGENLA^®), a modified long-acting form of recombinant human growth hormone (rhGH), is a valuable new option for the treatment of paediatric patients aged ≥ 3 years with growth disturbance due to insufficient GH secretion in the EU, and offers the convenience of once-weekly administration. In a phase 3 randomized trial, once-weekly somatrogon was non-inferior to once-daily somatropin (rhGH; standard therapy) in increasing height velocity in paediatric patients with GH deficiency (GHD). Once-weekly somatrogon was associated with a lower treatment burden than once-daily somatropin in another phase 3 randomized trial. Somatrogon is generally well tolerated, with injection site pain being the most frequent treatment-emergent adverse event. Somatrogon is available as a multi-dose prefilled pen for subcutaneous injection.

Plain Language Summary

Growth hormone deficiency (GHD) is a rare cause of growth failure in children. Affected children are usually much shorter than their peers and over time will tend to drop farther below the normal range. When GHD is recognised, children ordinarily begin treatment with recombinant human growth hormone (rhGH; somatropin) administered once daily, which while effective, has been associated with non-adherence and thus impaired therapeutic response. Somatrogon (NGENLA^®) is a novel long-acting rhGH that allows once-weekly administration. Administered as a once-weekly subcutaneous injection in a clinical trial in pre-pubertal children diagnosed with GHD who had not received prior rhGH therapy, somatrogon was no less effective than once-daily somatropin in terms of annualised height velocity following 12 months of treatment, with catch-up growth continuing over the longer term. In another clinical trial, once-weekly somatrogon reduced treatment burden relative to once-daily somatropin in treatment-experienced paediatric patients with GHD. When used to treat paediatric GHD, somatrogon was generally well tolerated, with a tolerability profile consistent with that of somatropin; most adverse events were mild or moderate in severity. Somatrogon is a valuable new treatment option for children and adolescents aged ≥ 3 years with growth disturbance due to insufficient GH secretion, and offers the convenience of once-weekly administration.