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The European Medicines Agency (EMA) has recommended marketing authorization for Tepezza (teprotumumab) for adults with moderate to severe thyroid eye disease (TED). 

TED is a rare autoimmune condition characterized by the inflammation of muscles, fat, and other tissues around and behind the eyes. Symptoms include eyeball protrusion from the eye socket, red and swollen eyelids, and double vision. 

In Europe, there are between 90 and 155 cases of TED per 100,000 persons. Around 3% of patients have severe TED, while the vast majority experience mild disease. 

The active substance of Tepezza is teprotumumab, a fully human immunoglobulin G1 (IgG1) monoclonal antibody. It works by binding to insulin-like growth factor 1 receptor (IGF-1R) to inhibit tissue inflammation and remodeling. This prevents the activation of orbital fibroblasts, which is thought to then prevent TED development and progression.

The recommendation comes after three randomized, placebo-controlled trials including 225 patients with active TED, and one trial involving 62 patients with chronic TED. Treatment took place over 24 weeks. 

Patients with active TED who took Tepezza experienced significant reductions of 2.0-2.3 mm in proptosis and reductions in inflammatory signs and symptoms, as assessed by the Clinical Activity Score, compared with those who received placebo. Those with chronic TED experienced a smaller reduction of 1.5 mm in proptosis.

Common side effects of the drug included muscle spasms, diarrhea, alopecia, hyperglycemia, fatigue, nausea, and headache. Some patients experienced hearing loss. Preclinical evidence suggested that the drug may also pose a risk for the developing fetus.

Tepezza will be available as a 500 mg powder or concentrate for solution or infusion. Treatment should be started and supervised by doctors experienced in diagnosing and treating TED.

Detailed recommendations for using Tepezza will be described in the summary of product characteristics, which will be published in the European public assessment report in all official European Union languages.

Annie Lennon is a medical journalist. Her writing appears on Medscape Medical News, WebMD, and Medical News Today, among other outlets.