EU nod for Pfizer and OPKO's once-weekly Ngenla

16 February 2022

The European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone Ngenla (somatrogon).

Developed by pharma giant Pfizer (NYSE: PFE) and OPKO Health (Nasdaq: OPK), Ngenla is a once-weekly injection approved 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.

Last month, the drug suffered a setback, when the US Food and Drug Administration issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. Laidlaw & Co analyst Yale Jen has previously estimated that the product could generate $1 billion in peak sales by 2026, if approved.

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