According to a story from Healio, the US Food and Drug Administration (FDA) has recently updated the indication for the drug teprotumumab (marketed as Tepezza). Approved for the treatment of thyroid eye disease, the updated indication expands the use of the drug for adult patients regardless of their level of disease activity or duration of their disease.
About Thyroid Eye Disease
Thyroid eye disease, which is also known as Graves’ ophthalmopathy, is an inflammatory disorder affecting the eyes and the surrounding tissues. The disease is autoimmune in nature and most common appears alongside Graves’ disease, an autoimmune illness that affects the thyroid. Hyperthyroidism is a significant risk factor. It can also appear in patients with Hashimoto’s thyroiditis. Women are more likely to affected than men, but men tend to be affected at older ages and have worse prognosis. Regardless, it can also appear on its own without comorbidity. Symptoms of the illness include lid lag, upper eyelid retraction, eye bulging, swelling, eye inflammation, and redness around the eyes. Severe cases, while rare, are a medical emergency that can threaten vision and inflict severe pain. In mild cases thyroid eye disease may eventually resolve on its own. Treatment may include corticosteroids, surgery, topical lubrication, and selenium supplementation. To learn more about thyroid eye disease, click here.
New Data, Expanded Indication
The agency issued the update to the drug indication in the days following the publication of results from the phase 4 trial. This study demonstrated that teprotumumab was linked to superior reduction in proptosis when compared to placebo in adult patients who had been diagnosed with the illness for a long time and had low levels of activity from the disease. 62 percent of patients had at least 2mm of reduction following 24 weeks of treatment.
The therapy was originally approved in 2020 following strong results in phase 2 and 3 clinical trials. The update will allow a greater number of patients to receive teprotumumab and begin treatment more promptly. The treatment was developed by Horizon Therapeutics.
