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Novo Nordisk Receives the CHMP's Positive Opinion for Sogroya (somapacitan)

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Novo Nordisk Receives the CHMP's Positive Opinion for Sogroya (somapacitan)

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  • The EMA’s CHMP accepted a positive opinion for the use of Sogroya (somapacitan)- once-weekly recommending its approval for the treatment of adults with growth hormone deficiency (AGHD)
  • The CHMP recommendation is based on P-III REAL 1 trial in 301 naïve adults and ongoing P-III REAL 4 trial investigating the efficacy and safety of somapacitan in children with AGHD
  • Sogroya received approval from the US FDA on 28 August- 2020 for AGHD and the Ministry of Health Labour and Welfare in Japan on 22 Jan- 2021

 ­ Ref: Novo Nordisk | Image: Novo Nordisk

Click here to­ read the full press release 

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