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

February 1, 2021 Auto Bot CHMP, Novo Nordisk, Opinion, Positive, receives, regulatory 0

Shots:

  • 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

Click here ­to­ read full press release/ article | Ref: NOVO NORDISK | Image: Pharmaceutical Technology

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