FDA Approves Novo Nordisk's Somapacitan for Pediatric Growth Disorders

The US United States===Food and Drug Administration (FDA) has approved three new pediatric indications for Novo Nordisk's once-weekly growth hormone, Novo Nordisk===Somapacitan (somapacitan-beco). Novo Nordisk===Somapacitan is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) with no catch-up growth by 2 years of age, and growth failure associated with Noonan Syndrome (NS). This expands on previous approvals for adults and children with growth hormone deficiency. The approval is based on the REAL8 study, which demonstrated Novo Nordisk===Somapacitan's non-inferiority to once-daily growth hormone treatments in terms of annualized height velocity. This once-weekly option aims to improve compliance for patients and caregivers by reducing the frequency of injections. Novo Nordisk has also submitted a supplemental application for Novo Nordisk===Somapacitan for Turner Syndrome, with a decision expected later this year.