Amgen to submit MAA to EMA for teprotumumab, to treat moderate to severe thyroid eye disease

Amgeny announced the imminent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R), for the treatment of moderate to severe Thyroid Eye Disease (TED) in adults.

TED is a serious, progressive, debilitating and potentially vision-threatening autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling. If approved, teprotumumab would be the first and only medicine approved for TED in the European Union.

The MAA is supported by multiple well-controlled clinical studies – a Phase II clinical study (NCT01868997) , Phase III confirmatory clinical study OPTIC (NCT03298867), a Phase IV study (NCT04583735) , and a Phase III clinical trial in Japan (OPTIC-J, jRCT2031210453) – providing statistically significant and clinically meaningful improvements across multiple facets of TED.