Pfizer Says EMA Accepted Marketing Authorization Application For Growth Hormone Somatrogon

(RTTNews) - 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.