Novo’s weekly growth-hormone treatment gains another European recommendation

Novo Nordisk ($NVO) received a positive European advisory opinion for once-weekly Sogroya in children with idiopathic short stature and persistent growth disturbance. The proposed expansion is supported by the REAL8 study, which found the weekly treatment non-inferior to daily growth-hormone therapy on height velocity after 52 weeks.

The recommendation follows earlier positive opinions covering children born small for gestational age and those with Noonan syndrome. Novo expects European Commission decisions on the proposed additions later this year. Sogroya already has European authorization for growth-hormone deficiency in specified adult and pediatric populations; the update concerns broader eligibility, not its first approval. Non-inferiority also does not demonstrate that the weekly treatment produces superior growth outcomes.

Sources:

• Novo Nordisk — Sogroya recommendation and REAL8 evidence, company release reprint