OPKO and Pfizer Announce Positive Phase 3 Top-Line Results for Somatrogon, an Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency
Opko Health, Inc. (OPK)
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Source: GlobeNewswire
— Results demonstrated potential to reduce current dosing frequency from once-daily to a single weekly injection — MIAMI and NEW YORK, Oct. 21, 2019 (GLOBE NEWSWIRE) -- OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE) announced today that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint of non-inferiority to daily GENOTROPIN® (somatropin) for injection, as measured by annual height velocity at 12 months. Top-line results from the study demonstrated that treatment with somatrogon dosed once-weekly in pre-pubertal children with GHD was non-inferior to somatropin dosed once-daily with respect to height velocity at 12 months of treatment (the primary endpoint); the least square mean was higher in the somatrogon group (10.12 cm/year) than in the somatropin group (9.78 cm/year); the treatment difference (somatrogon – somatropin) in height velocity (cm/year) was 0.33 with
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