- CHMP recommended once-weekly Sogroya (somapacitan) for children in Europe with idiopathic short stature (ISS) and persistent growth disturbance; on approval it would be the first and only growth hormone treatment cleared for ISS in the EU.
- The opinion follows the May 2026 CHMP recommendation of Sogroya for short stature in children born small for gestational age and with Noonan Syndrome; the European Commission decision covering all three indications is expected later this year.
- REAL8 trial data supporting the opinion showed once-weekly Sogroya was non-inferior to once-daily growth hormone for mean annualised height velocity at Week 52 in children with ISS, born small for gestational age and Noonan Syndrome.
- One day earlier, the same CHMP panel endorsed Frehemgo, Novo's injectable therapy targeting hemophilia A.
Quotes
“For too long, treatment options for many children with growth disorders have been limited. Building on our decades of experience in growth hormone medicines, we’re committed to changing that. Today’s approval recommendation from the CHMP is a very important step forward for children and their families affected by ISS across Europe”
“Through our research and relationships with the community, we know that 70% of families raising children with ISS and other growth disorders feel unseen, and that the impact on their child's daily life simply isn't recognised”