Aristides Maniatis, MD, FAAP, discusses Sogroya benefits for pediatric growth disorders

The clinical impact of the FDA’s approval of somapacitan-beco (Sogroya; Novo Nordisk) represents a significant development in pediatric endocrinology, as highlighted by Aristides Maniatis, MD, FAAP, founder of Rocky Mountain Pediatric Endocrinology.

This once-weekly growth hormone is approved for children 2.5 years and older with growth failure because of growth hormone deficiency, idiopathic short stature (ISS), Noonan syndrome, or being born small for gestational age (SGA). This approval marks a pivotal shift by providing a treatment option that significantly reduces the injection burden for young patients and their caregivers.

Maniatis emphasizes that the transition from daily injections to a once-weekly regimen offers families 313 injection-free days per year. This reduction in frequency directly addresses the treatment burden that often leads to nonadherence, such as needle phobias or household anxiety. By simplifying the schedule, Sogroya fits more seamlessly into a child’s routine, which is a key factor in ensuring they reach long-term growth goals.

The approval is supported by data from the phase 3 REAL8 trial, where Sogroya demonstrated noninferiority to daily somatropin. In ISS and SGA cohorts, the annualized height velocity for patients on the once-weekly treatment averaged between 10.5 and 11 cm per year, comparable to daily therapy. Notably, in children with Noonan syndrome, Sogroya showed a superior estimated mean height velocity of 10.4 cm per year compared with 9.2 cm per year with daily somatropin.

Safety profiles remained consistent with established therapies, with common adverse events including respiratory tract infections, nasopharyngitis, and headaches. Injection site reactions were reported at rates similar to daily injections, with no new safety signals emerging. Maniatis notes that having an effective, long-acting alternative is a major step forward, providing pediatricians with a versatile tool to tailor therapy to the specific lifestyle and psychological needs of their patients.

No relevant disclosures.

Reference

FDA approves Novo Nordisk’s Sogroya as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications. News release. Novo Nordisk. February 27, 2026. Accessed February 27, 2026. https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-sogroya-as-the-first-and-only-once-weekly-long-acting-growth-hormone-for-three-additional-pediatric-indications-302699946.html