AMGEN EUROPE B.V.

EMA Recommends Approval of Tepezza for Thyroid Eye Disease, First Targeted Treatment in EU

- The European Medicines Agency has recommended approval of Tepezza (teprotumumab) for adults with moderate to severe thyroid eye disease, marking the first targeted therapy for this condition in the EU. - Clinical trials demonstrated significant reduction in eye protrusion (2-2.3mm) and inflammatory symptoms after 24 weeks of Tepezza treatment compared to placebo, providing a non-surgical alternative for patients. - Despite promising efficacy, Tepezza carries risks including potential permanent hearing loss and fetal development concerns, prompting additional risk minimization measures to be implemented alongside approval.