Pfizer and Opko’s Ngenla injection gets marketing authorisation in EU

Pfizer and Opko Health recently announced that the European Commission has granted marketing authorisation for the next-generation long-acting recombinant human growth hormone Ngenla (somatrogon), a once-weekly injection to treat children and adolescents from three 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, Pfizer informed in a statement.

GHD is a rare disease characterised by the inadequate secretion of the growth hormone, somatropin, from the pituitary gland, and affects one in approximately 4,000 to 10,000 children worldwide. The disease can be caused by genetic mutations or acquired after birth. Without treatment, affected children will have persistent growth attenuation and a very short height in adulthood, and puberty may be delayed. Children may also experience other problems with physical health and mental well-being, the statement added.

It also said that the European Union (EU) marketing authorisation of Ngenla was supported by results from a global, randomised, 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.

The marketing authorisation of Ngenla is valid in all EU member states as well as in Iceland, Norway and Liechtenstein, the statement concluded.