Amgen 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.1 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 2 clinical study (NCT01868997)1, Phase 3 confirmatory clinical study OPTIC (NCT03298867), a Phase 4 study (NCT04583735), and a Phase 3 clinical trial in Japan (OPTIC-J, jRCT2031210453) - providing statistically significant and clinically meaningful improvements across multiple facets of TED, including in proptosis and diplopia, among the 287 total patients studied.

Teprotumumab is approved for TED in the U.S., Brazil and the Kingdom of Saudi Arabia under the brand name TEPEZZA®?, where it is administered to patients through an intravenous (IV) infusion once every three weeks for a total of eight infusions over the course of about five months. In March 2024, Amgen submitted a marketing authorization application to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain, a New Drug Submission (NDS) to Health Canada and an application to the Therapeutic Goods Administration (TGA) in Australia for teprotumab.