EU approves Ngenla in growth hormone deficient children – Pfizer + OPKO Health
Pfizer and OPKO Health announced that the European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone Ngenla (somatrogon), a once-weekly injection to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. Ngenla provides pediatric patients, their caregivers and healthcare providers with a new treatment option for growth hormone deficiency (GHD) that reduces the frequency of required injections from once daily to once weekly.
The European Union (EU) marketing authorization of Ngenla was supported by results from a global, randomized, open-label, active-controlled Phase III study which evaluated the safety and efficacy of once-weekly Ngenla compared to once-daily Genotropin (somatropin). The study met its primary endpoint of Ngenla non-inferiority compared to Genotropin, as measured by annual height velocity at 12 months. Ngenla was generally well tolerated in the study and had a safety profile comparable to Genotropin.