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FX.co ★ Amgen Announces Imminent Submission Of MAA To European Medicines Agency For Teprotumumab

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

Biopharmaceutical giant, Amgen, has announced its plans to submit a Marketing Authorization Application for Teprotumumab to the European Medicines Agency. Teprotumumab is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor-1 receptor. It has been developed for the treatment of moderate to severe Thyroid Eye Disease (TED) in adults. If approved, it would mark a significant milestone as the first and only medicine for TED in the European Union.

Teprotumumab, marketed under the brand name TEPEZZA, has already gained approval for TED treatment in countries like the U.S., Brazil, and the Kingdom of Saudi Arabia.

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