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Pfizer Says EMA Accepted Marketing Authorization Application For Growth Hormone Somatrogon

Pfizer Inc. (PFE) and OPKO Health Inc. (OPK) announced Friday that the European Medicines Agency or EMA has validated for review the Marketing Authorization Application for somatrogon. Pfizer expects a decision from the European Commission in 2022.

The company said somatrogon is a long-acting recombinant human growth hormone administered once-weekly for the treatment of pediatric patients with growth hormone deficiency.

The somatrogon Phase 3 trial enrolled 224 pediatric patients in a randomized, open-label, active-controlled study in over 20 countries.

The US Food and Drug Administration accepted the initial Biologics License Application in January 2021 and a New Drug Application was submitted to PMDA in Japan for somatrogon in January.

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