Approved: First Rx for Thyroid Eye Disease

FDA approves Tepezza (teprotumumab-trbw) to treat thyroid eye disease

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first-ever medication for thyroid eye disease.

This medication is found under the following names: Tepezza and teprotumumab-trbw. Approved to treat adults with thyroid eye disease, Tepezza is injected into the vein.

Thyroid eye disease, a rare condition, is marked by the outward bulging of the eyes. This bulging is due to the inflammation of the muscles and fatty tissues behind the eye, which then causes the eyes to be pushed forward.

Those with thyroid eye disease often experience symptoms like eye pain, double vision and even problems closing the eyes. Furthermore, this eye condition can interfere with the ability to perform daily activities, such as driving and even working.

"Currently, there are very limited treatment options for this potentially debilitating disease," said Dr. Wiley Chambers, deputy director of the FDA's Division of Transplant and Ophthalmology Products, in a press release. "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."

Common side effects that may occur with Tepezza include but are not limited to muscle spasms, nausea or diarrhea, hair loss, feeling very tired and headache.

This medication is not recommended for women who are pregnant. The FDA said women should check to see if they are pregnant before starting treatment with this medication.

This new approval was granted to Horizon Therapeutics Ireland DAC.

Written by Anyssa Garza, PharmD, BCMAS

Review Date: 
January 25, 2020