RTTNews | Feb 26, 2021 07:29AM EST

07:28 Friday, February 26, 2021 (RTTNews.com) - 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.

Read the original article on RTTNews ( https://www.rttnews.com/3173387/pfizer-says-ema-accepted-marketing-authorization-application-for-growth-hormone-somatrogon.aspx)

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