EMA validates filing of Somatrogon to treat growth hormone deficiency.- Pfizer

Pfizer announced that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for Somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022. The submission is supported by the results of a global, Phase III trial evaluating the safety and efficacy of somatrogon administered once-weekly to pediatric patients with GHD. This study met its primary endpoint of non-inferiority compared to Genotrophin (somatropin) for injection administered once daily, as measured by annual height velocity at 12 months. In addition, change in height standard deviation scores at 6 and 12 months, key secondary endpoints, were higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. Moreover, at 6 months, change in height velocity, another key secondary endpoint, was higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. These common measures of growth are employed in the clinical setting to measure the potential level of catch-up growth that subjects may experience relative to the heights of their age and gender matched peers.Somatrogon was generally well tolerated in the study and comparable to that of somatropin administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.