Novo Nordisk: CHMP approves Sogroya
(CercleFinance.com) - Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending Sogroya (somapacitan), administered once weekly, as an alternative to endogenous growth hormone in children and adolescents with growth failure due to hormone deficiency.
This will help improve the lives of children as young as three years old by offering a simpler treatment option with fewer injections, it said.
The REAL4 phase 3 study showed that the once-weekly subcutaneous injection of Sogroya worked as well as the daily injection of Norditropin. This means that at the end of the trial period, prepubertal children treated with Sogroya once a week had similar growth to those treated with Norditropin once daily.
The European Commission (EC) will now examine the CHMP's positive opinion, and a final decision on marketing authorisation is expected in the coming months. If approved, Sogroya will be available in certain European countries from Q4 2023: it was approved by the US FDA in April 2023.
Copyright (c) 2023 CercleFinance.com. All rights reserved.
This will help improve the lives of children as young as three years old by offering a simpler treatment option with fewer injections, it said.
The REAL4 phase 3 study showed that the once-weekly subcutaneous injection of Sogroya worked as well as the daily injection of Norditropin. This means that at the end of the trial period, prepubertal children treated with Sogroya once a week had similar growth to those treated with Norditropin once daily.
The European Commission (EC) will now examine the CHMP's positive opinion, and a final decision on marketing authorisation is expected in the coming months. If approved, Sogroya will be available in certain European countries from Q4 2023: it was approved by the US FDA in April 2023.
Copyright (c) 2023 CercleFinance.com. All rights reserved.