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
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