Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending once-weekly Sogroya (somapacitan) for replacement of endogenous growth hormone (GH) in children aged three years and above, and adolescents with growth failure due to growth hormone deficiency.
Bagsværd, Denmark, 26 May 2023 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion,...
Bagsværd, Denmark, 26 May 2023 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending once-weekly Sogroya® (somapacitan) for replacement of endogenous growth hormone (GH) in children aged three years and above, and adolescents with growth failure due to growth hormone deficiency.
Atlanta, Georgia (US), 12 June 2022 – Today, Novo Nordisk announced results of once-weekly Sogroya® (somapacitan) injection in helping children achieve growth targets of annualised height velocity (AHV).1 These phase 3 results from the REAL 4 study, in prepubertal children with growth hormone deficiency (GHD), were presented today at the Endocrine Society’s Annual Meeting (ENDO 2022) in Atlanta, Georgia (US).
Novo Nordisk`s Biological Somapacitan-Beco Receives Supplemental Approval In US
Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU.