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

Shots:

• 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

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