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Novo Nordisk Receives the EMA’s CHMP Positive Opinion of Sogroya (somapacitan) for Children and Adolescents with Growth Hormone Deficiency

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Novo Nordisk Receives the EMA’s CHMP Positive Opinion of Sogroya (somapacitan) for Children and Adolescents with Growth Hormone Deficiency

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  • The EMA’s CHMP has adopted a positive opinion recommending Sogroya (qw) for the replacement of endogenous GH in children aged ≥3yrs. & adolescents with growth failure due to growth hormone deficiency
  • The opinion emerged following the data from the P-III study (REAL4) evaluating Sogroya (0.16mg/kg/week, SC) vs Norditropin (0.034 mg/kg/day, SC) in a ratio (2:1) in 200 treatments naïve, prepubertal children which showed a similar growth as children treated with Norditropin
  • Annualised height (11.2 vs 11.7cm/yr.) with no statistical difference, was well tolerated with a similar safety & tolerability profile to the well-known profile of Norditropin. The EC’s final decision on the marketing authorization is expected in the coming months

Ref: Novo Nordisk | Image: Novo Nordisk

Related News:- Novo Nordisk Entered into a Research and Development Collaboration with Life Edit Therapeutics to Develop Gene Editing Therapies for Rare and Cardiometabolic Diseases

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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