Pfizer Inc. and OPKO Health Inc. on Friday said the European Medicines Agency validated for review their marketing authorization application for somatrogon, a once-weekly human-growth hormone for pediatric patients with growth-hormone deficiency.
New York drug maker Pfizer said somatrogon, if approved, would help reduce the burden of daily growth-hormone injections, adding that it expects a decision from the European Commission in 2022.
Pfizer and OPKO, a Miami healthcare-services company, signed a worldwide agreement in 2014 to develop and commercialize somatrogon for growth-hormone deficiency. The U.S. Food and Drug Administration in January accepted for review the companies' application for somatrogon.
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