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Pfizer and OPKO Reports Results of Somatrogon in P-III Study for Children with Growth Hormone Deficiency

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Pfizer and OPKO Reports Results of Somatrogon in P-III Study for Children with Growth Hormone Deficiency

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  • The P-III study involves assessing of Somatrogon (qw) vs Genotropin (somatropin-qd) for injection- in 224 pre-pubertal- treatment-naive children in a ratio (1:1) with growth hormone deficiency across 20 countries
  • The P-III study resulted in meeting its 1EPs of non-inferiority to somatropin with respect to height velocity at 12 mos. of treatment- least-square mean (10.12 vs 9.78 cm/year)- 2EPs: treatment difference (0.33)- higher change in height standard deviation scores @6 & 12mos.- higher change in height velocity- well-tolerated
  • Somatrogon is an investigational long-acting human GH one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic hCG at the N terminus and two copies at the C-terminus and has received FDA & EMA’s ODD to treat children and adults with GHD

Click here to­ read full press release/ article | Ref: Pfizer | Image: Specialty Pharma Journal


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