SOGROYA (somapacitan) - Growth hormone deficiency

The Committee deems that the clinical benefit of SOGROYA (somapacitan) 5 mg/1.5 ml, 10 mg/1.5 ml, 15 mg/1.5 ml solution for injection in pre-filled pen is substantial in the replacement of endogenous growth hormone (GH) in children aged 3 years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric GHD).

Growth hormone deficiency in children and adolescents

The Committee deems that SOGROYA (somapacitan) 5 mg/1.5 ml, 10 mg/1.5 ml, 15 mg/1.5 ml solution for injection in pre-filled pen provides no clinical added value (CAV V) compared to NORDITROPIN (somatropin) in the replacement of endogenous growth hormone (GH) in children aged 3 years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric GHD).

Growth hormone deficiency in adults

The Committee deems that SOGROYA (somapacitan) 5 mg/1.5 ml, 10 mg/1.5 ml, 15 mg/1.5 ml solution for injection in pre-filled pen provides no clinical added value (CAV V) in the current care pathway for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (adult GHD), which includes the relevant comparators.