Posted by Michael Wonder on 29 May 2023
Once weekly Sogroya (somapacitan) receives CHMP positive opinion for expanded use in children and adolescents with growth hormone deficiency
26 May 2023 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending once weekly Sogroya (somapacitan) for replacement of endogenous growth hormone in children aged three years and above, and adolescents with growth failure due to growth hormone deficiency.
The positive opinion is based on data from the Phase 3 REAL4 study, which showed that once-weekly subcutaneous injection of Sogroya worked as well as daily injection of Norditropin (somatropin).
