Amgen Prepares to Present Marketing Authorization Application for Teprotumumab to the European Medicines Agency

Amgen (NASDAQ:AMGN) has announced its forthcoming submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab. Teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R), is aimed at treating moderate to severe Thyroid Eye Disease (TED) in adults. TED is a significant autoimmune disease characterized by proptosis (eye bulging), diplopia (double vision), eye pain, redness, and swelling, with potential vision-threatening complications. If approved, teprotumumab would be the first medicine of its kind authorized for TED in the European Union.

Jay Bradner, Amgen’s executive vice president of Research and Development and chief scientific officer, expressed enthusiasm for providing a much-needed treatment option for the TED community in Europe. He highlighted teprotumumab’s potential to address the underlying cause of the disease, offering a non-surgical alternative to current management approaches involving steroids and invasive surgeries, which carry inherent risks.

The MAA submission is backed by several well-controlled clinical studies, including a Phase 2 trial (NCT01868997), Phase 3 confirmatory trial OPTIC (NCT03298867), a Phase 4 study (NCT04583735), and a Phase 3 trial in Japan (OPTIC-J, jRCT2031210453). These studies have demonstrated statistically significant and clinically meaningful improvements across various aspects of TED, including proptosis and diplopia, among the 287 patients involved. Notably, improvements in proptosis were observed as early as six weeks into treatment, with sustained enhancement throughout the 24-week treatment duration. Teprotumumab has exhibited a well-established safety profile in these trials.

Mario Salvi, MD, founder & head of Graves Orbitopathy Center Aldo, Fondazione IRCCS Ca’ Granda, Milano, emphasized the urgent need for approved TED treatments in Europe. He highlighted the disease’s profound impact on patients’ daily lives, extending beyond physical symptoms to affect overall well-being and mental health.

While teprotumumab, marketed as TEPEZZA® in the U.S., Brazil, and the Kingdom of Saudi Arabia, is already approved for TED treatment in these regions, its availability in Europe remains pending regulatory approval. In addition to the submission to the EMA, Amgen has initiated regulatory processes in other countries, including Great Britain, Canada, Australia, and Japan.

TED, a debilitating autoimmune condition often associated with Graves’ disease, poses a serious threat to vision and overall health. Its symptoms range from dry eyes and swelling to eye protrusion and double vision. TEPEZZA® offers a promising therapeutic option for managing TED, with its efficacy and safety profile underlined by rigorous clinical evaluation.

TEPEZZA® is indicated for the treatment of Thyroid Eye Disease regardless of disease activity or duration. While generally well-tolerated, TEPEZZA® may induce infusion reactions, exacerbate preexisting inflammatory bowel disease, or elevate blood glucose levels. Other potential adverse reactions include muscle spasm, nausea, alopecia, diarrhea, fatigue, and hearing impairment. Close monitoring and appropriate management strategies are recommended to ensure patient safety throughout treatment.

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