Tepezza is a monoclonal antibody (mAb) pharmaceutical product
… Tepezza (teprotumumab-trbw) is FDA approved just in time for Rare Disease Day

Horizon Therapeutics Introduces Tepezza (teprotumumab-trbw)

Tepezza is the first FDA-approved therapy for the treatment of active Thyroid Eye Disease

John G. Baresky

Tepezza is an advanced pharmaceutical therapy

Tepezza is a highly specialized pharmaceutical biologic or biotherapy drug treatment as it is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R). Monoclonal antibodies are proteins produced in laboratories which bind to a specifically targeted substance. The first mAb was produced in 1986.

Thyroid eye disease challenges

TED, also referred to as Graves’ Orbitopathy or Ophthalmopathy, is an autoimmune condition. Its symptoms include outward bulging of the eye that can trigger a series of issues including double vision, eye pain, light sensitivity or problems with closing the eye.

Deputy Director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research Wiley Chambers MD provides these insights about Tepezza:

“Currently, there are very limited treatment options for this potentially debilitating disease. This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non-surgical treatment option.”

Horizon will conduct a post-approval study for Tepezza

As part of the approval, Horizon will continue studying Tepezza’s performance in a post-marketing study. It will focus on the drug’s safety in a larger patient population. Ophthalmologists and other medical professionals that care for TED patients will embrace this FDA-approved treatment option. Their data and experience with Tepezza will provide further insights for the medical community and FDA to learn from.

Horizon Therapeutics corporate information

Horizon Therapeutics (formerly known as Horizon Pharma) is based in Dublin, Ireland with the main U.S. office located in Lake Forest, Illinois (a Chicago suburb). The company has a diverse, niche-focused portfolio of products including:

  • Buphenyl
  • Duexis
  • Krystexxa
  • Pennsaid
  • Procysbi
  • Ravicti
  • Rayos
  • Vimovo

Authentic, fact-based healthcare content marketing writing for medical, business, academic, patient and consumer audiences https://www.BareSkyMarketing.com/

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