Amgen Announces Imminent Submission Of MAA To European Medicines Agency For Teprotumumab

(RTTNews) - Amgen (AMGN) announced the imminent submission of a Marketing Authorization Application to the European Medicines Agency for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor, for the treatment of moderate to severe Thyroid Eye Disease in adults. The company noted that, if approved, teprotumumab would be the first and only medicine approved for TED in the European Union.

Teprotumumab is approved for TED in the U.S., Brazil and the Kingdom of Saudi Arabia under the brand name TEPEZZA.

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