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FDA Approves First Treatment for Thyroid Eye Disease

Posted on February 29, 2020

The US Food and Drug Administration (FDA) approved teprotumumab-trbw (Tepezza) for the treatment of adults with thyroid eye disease. It is the first drug approved for the treatment of this disease.

Thyroid eye disease is a rare condition where the muscles and fatty tissues behind the eye become inflamed, which can lead to proptosis and may cause symptoms such as eye pain, double vision, light sensitivity or difficulty closing the eye. People with thyroid eye disease may experience a decrease in quality of life.

Approval of teprotumumab-trbw was based on the results of 2 studies enrolling a total of 170 patients with active thyroid eye disease who were randomized to either receive teprotumumab-trbw or a placebo. In the first study, 71% of patients who were administered teprotumumab-trbw demonstrated a >2 mm reduction in proptosis compared to 20% who were administered placebo. In the second study, 83% of patients receiving teprotumumab-trbw demonstrated a >2 mm reduction in proptosis compared to 10% who were given a placebo.

The most common adverse reactions observed in patients treated with teprotumumab-trbw include muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing loss, dry skin, dysgeusia, and headache.

“Today’s approval marks an important milestone for the treatment of thyroid eye disease. 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,” said Wiley Chambers, MD, deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

For more information, read the full FDA press release, here.

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