Amgen announces imminent submission of MAA to EMA for teprotumumab

Amgen announced the imminent submission of a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor, or IGF-1R, for the treatment of moderate to severe Thyroid Eye Disease, or TED, in adults. TED is a serious, progressive, debilitating and potentially vision-threatening autoimmune disease that can cause proptosis, diplopia, 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, 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. Additionally, the studies assessed TED signs and symptoms such as pain, inflammation, redness and functional vision. Clinical improvements were seen in proptosis as early as six weeks, with continued improvement across the 24-week treatment period.2 Teprotumumab has a well-established safety profile.