Amgen (NASDAQ:AMGN) today 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.
"We are enthusiastic to bring a much-needed medicine to the Thyroid Eye Disease community in Europe by leveraging Amgen's strong reputation and broad infrastructure in the region," said Jay Bradner, executive vice president of Research and Development and chief scientific officer at Amgen. "This disease is currently managed with steroids and invasive surgeries, both of which carry their own set of risks. Having access to a non-surgical option like teprotumumab that not only treats the signs and symptoms, but also targets the underlying cause of the disease represents a major advance for patients."