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.
"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."
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.
"People living with Thyroid Eye Disease, a painful and potentially sight-threatening disease, have no approved treatment options in Europe at this time," said Mario Salvi, MD, founder & head of Graves Orbitopathy Center Aldo, Fondazione IRCCS Ca' Granda, Milano. "When considering the impact of this disease on patients, it's important to look beyond the symptoms, like eye bulging and double vision, and recognize that the inability to work, drive or even look or feel like themselves has a serious negative impact on overall well-being and mental health."
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.1,2
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 teprotumumab. Teprotumumab is also under review by the Ministry of Health, Labour and Welfare (MHLW) in Japan.
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