Complete Response Letter for somatrogon for the treatment of growth hormone deficiency.- Pfizer + Opko Health

Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.

Japan’s Ministry of Health, Labour and Welfare approved Ngenla (somatrogon) Inj. 24 mg Pens and 60mg Pens, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. In 2021, Health Canada approved Ngenla for the long-term treatment of pediatric patients who have GHD, and Australia’s Therapeutic Goods Administration (TGA) approved Ngenla for the long-term treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone.

In December 2021, the Committee for Medicinal Products for Human Use (CHMP) of EMA issued a positive opinion recommending somatrogon for marketing authorization in the EU, to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.