Research & Development
Novo Nordisk receives positive CHMP opinion for once-weekly treatment for children and adolescents with growth hormone deficiency
26 May 2023 -

Danish pharmaceutical company Novo Nordisk A/S (CPH:NOVO-B) (NYSE:NVO) said on Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended once-weekly Sogroya (somapacitan) for the treatment of growth hormone deficiency in children and adolescents.

Growth hormone deficiency in children can lead to short stature and other growth-related health problems. Current treatment typically requires daily injections of growth hormone, which can be burdensome and affect adherence, especially in children.

The positive CHMP opinion represents a step forward in providing a simpler treatment option for children as young as three years old.

The recommendation was based on data from the phase 3 REAL4 study, which demonstrated the efficacy of once-weekly subcutaneous injection of Sogroya compared to once-daily Norditropin (somatropin). The European Commission will review the opinion, with a final decision expected in the coming months.

Sogroya received approval from the US Food & Drug Administration (FDA) in April 2023. Subject to approval by the European Commission, it is anticipated to be available in some European countries starting in Q4 2023.