Amgen Soon to Seek European Marketing Authorization for Teprotumumab

Amgen Soon to Seek European Marketing Authorization for Teprotumumab

By, Admin 1 May 2024

Amgen to seek European marketing authorization for teprotumumab to treat moderate to severe thyroid eye disease

Overview

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. If approved, teprotumumab would be the first and only medicine approved for TED in the European Union.

Words from CSO: Amgen

  • "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."

Phase 2 Clinical Study

  • The MAA is supported by multiple well-controlled clinical studies - a phase 2 clinical study (NCT01868997)1, Phase 3 confirmatory clinical study OPTIC (NCT03298867)2, a phase 4 study (NCT04583735)3, 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. 
  • Teprotumumab has a well-established safety profile.

From Graves Orbitopathy Center Aldo

  • "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 Approval

Teprotumumab is approved for TED in the US, 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.

Amgen Submission in 2024

  • 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.

About TED

  • TED is a serious, progressive, debilitating and potentially vision-threatening autoimmune disease. It often occurs in people living with Graves' disease, but is a distinct disease that is caused by autoantibodies activating an insulin-like growth factor-1 receptor (IGF-1R)-mediated signalling complex on cells within the retro-orbital space. 
  • This leads to a cascade of negative effects, which may cause long-term, irreversible damage, including blindness. 
  • Signs and symptoms of TED may include dry eyes and grittiness; redness, swelling and excessive tearing; eyelid retraction; proptosis; pressure and/or pain behind the eyes; and diplopia.

Marketed Name

Teprotumumab is marketed as Tepezza (teprotumumab-trbw) in the United States. Teprotumumab is not currently approved for commercial use in Europe.

Indication

Tepezza is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration.

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