Amgen recently announced its plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab, a fully human monoclonal antibody designed to treat moderate to severe Thyroid Eye Disease (TED) in adults. TED is a serious autoimmune condition that can lead to eye bulging, double vision, eye pain, and swelling, potentially threatening vision.

Jay Bradner, Amgen's executive vice president of Research and Development and chief scientific officer, expressed excitement about providing a much-needed treatment option for the TED community in Europe. He emphasized the significance of offering a non-surgical alternative like teprotumumab, which not only addresses symptoms but also targets the underlying cause of the disease.

The submission is backed by several well-controlled clinical studies, including a Phase 2 study, Phase 3 confirmatory study OPTIC, a Phase 4 study, and a Phase 3 trial in Japan (OPTIC-J). These studies demonstrated significant improvements in various aspects of TED, such as proptosis and diplopia, among the patients evaluated. Moreover, improvements in symptoms like pain, inflammation, redness, and functional vision were observed. Notably, improvements in proptosis were evident as early as six weeks into treatment, with continued enhancement over the 24-week period. Teprotumumab has a well-established safety profile.

Mario Salvi, MD, highlighted the impact of TED on patients' overall well-being and mental health, emphasizing the urgent need for effective treatment options in Europe.

Teprotumumab, marketed as TEPEZZA (teprotumumab-trbw) in the United States, is currently approved for TED in the U.S., Brazil, and the Kingdom of Saudi Arabia. The drug is administered via intravenous (IV) infusion once every three weeks for a total of eight infusions over approximately five months.

In March 2024, Amgen submitted marketing authorization applications for teprotumumab to regulatory authorities in Great Britain, Canada, and Australia, and it is also under review by the Ministry of Health, Labour and Welfare (MHLW) in Japan.

Thyroid Eye Disease (TED) is a severe autoimmune condition often associated with Graves' disease. It is characterized by autoantibodies activating an insulin-like growth factor-1 receptor (IGF-1R)-mediated signaling complex, leading to various symptoms including eye bulging, double vision, and eye pain.

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. Important safety information includes warnings about infusion reactions, exacerbation of preexisting inflammatory bowel disease (IBD), hyperglycemia, and potential hearing impairment, among others.

The most common adverse reactions observed in clinical trials include muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, and hearing impairment.

 

Source: prnewswire.com

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