Horizon Therapeutics Introduces Tepezza (teprotumumab-trbw)
Tepezza is the first FDA-approved therapy for the treatment of active Thyroid Eye Disease
Horizon Therapeutics (NASDAQ: HZNP) has earned FDA approval for its new thyroid eye disease Tepezza (teprotumumab-trbw) pharmaceutical product. Thyroid eye disease (TED) is a healthcare condition that involves inflammation of the eyes, eye muscles, eyelids, tear glands and fatty tissues behind the eye.
Tepezza may help patients avoid more serious conditions with their eyes as a result of TED including the potential need for surgical procedures. Tepezza is administered via infusion once every 3 weeks for a total of 8 infusions.
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.
Based on Tepezza’s unique attributes and focus on TED, Horizon requested and received orphan drug status from the FDA with the product’s approval.
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.
Graves’ eye disease is triggered when immune cells attack the thyroid gland that responds by overproducing thyroid hormone. This enlarges the thyroid gland and hormone overload. These symptoms span increased heartbeat and elevated blood pressure, heart palpitations, excessive perspiration, tiredness, loss of weight, heat intolerance plus hair and scalp issues. As the immune system attacks tissues around the eyes, it causes the eye muscles plus fat or surrounding skin to bulge.
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.”
“Additionally, thyroid eye disease is a rare disease that impacts a small percentage of the population, and for a variety of reasons, treatments for rare diseases are often unavailable. This approval represents important progress in the approval of effective treatments for rare diseases, such as thyroid eye disease.”
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:
Horizon generates approximately $1.25 billion in sales annually and was founded in 2005.
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