The European Medicines Agency has recommended granting a marketing authorisation in the European Union (EU) for Tepezza (teprotumumab), for the treatment of adults with moderate to severe thyroid eye disease.
Thyroid eye disease, also known as Graves’ eye disease, is a rare autoimmune disease that triggers inflammation of muscles, fat, and other tissues around and behind the eyes. This can cause the eyes to bulge (or protrude), and other symptoms, including puffy eyelids, redness in the eye and irritation, eye pain, double vision, and eyelid retraction (when the upper and/or lower eyelids are pulled back more than normal). In severe cases, thyroid eye disease can cause vision loss and facial disfigurement, EMA said.
Treatment options for moderate to severe cases are limited and most patients are treated with corticosteroids, with some patients needing multiple reconstructive surgeries, it added.