Novo Nordisk has received approval from the US Food and Drug Administration for three new indications for its once‑weekly growth hormone Sogroya, expanding its use to children aged 2.5 years and older with idiopathic short stature, those born small for gestational age without catch‑up growth by age two, and those with growth failure linked to Noonan syndrome.
The company said the decision broadens treatment options for families and clinicians while offering an alternative to daily injections, which can be difficult to maintain.
Nicky Kelepouris, Rare Endocrine Disorders‑US Medical Lead, said: “Daily injections have defined the growth disorder treatment paradigm for more than 40 years. Our scientific leadership and focus on advancing care in rare diseases led us to the development of Sogroya – a once weekly growth hormone therapy – which may help address the challenge of daily injections while offering patients and families a therapeutic option that delivers efficacy and safety.”
Kelepouris added: “These new approvals expand the patient populations that can be helped by Sogroya and reflect our strategic focus on delivering meaningful, evidence‑based innovation for children living with growth disorders.”
The company highlighted that adherence to 365 injections a year can be challenging for children and caregivers. Dr Aristides Maniatis, Founder of Rocky Mountain Pediatric Endocrinology and a trial investigator, said: “Families and healthcare professionals now have the option to consider a once‑weekly growth hormone as treatment with 313 injection free days per year for their children 2.5 years and older with ISS, NS, and born SGA.” He added: “Sogroya is an effective alternative to daily injections that supports children’s growth goals and may help fit into their routine.”
The approvals are supported by the REAL8 study, which showed Sogroya was non‑inferior to daily growth hormone therapy across all three indications. Adverse reactions occurring in at least 10% of patients included respiratory tract infection, nasopharyngitis, ear infection and diarrhoea.
Novo Nordisk has also submitted a supplemental application seeking approval of Sogroya for Turner syndrome, with a decision expected later this year.
