First and only drug for Thyroid Eye Disease

Horizon Therapeutics announced the FDA approval of TEPEZZA (teprotumumab-trbw), the first and only medicine for the treatment of Thyroid Eye Disease (TED).

TED is a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation and facial disfigurement.

TEPEZZA is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions, providing a non surgical treatment option for patients.

“Today is a great day for people living with Thyroid Eye Disease, a rare, vision-threatening disease that previously had no FDA-approved treatment options,” said Timothy Walbert, chairman, president and CEO, Horizon. 

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“The FDA approval of TEPEZZA is momentous for the TED community and has the potential to change the treatment paradigm for TED – providing new hope for people who are living with this horrible, vision-threatening disease,” said Raymond Douglas, M.D., Ph.D., director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Centre and co-principal investigator of the TEPEZZA Phase III confirmatory clinical trial. “This news brings forward a medicine for patients that targets the underlying biology of the disease and has been shown to significantly improve eye bulging and double vision, which are the most debilitating aspects of the disease.”

The FDA approval of TEPEZZA is supported by a robust body of clinical evidence, including statistically significant, positive results from the Phase II clinical study, as well as the Phase 3 confirmatory clinical study OPTIC. The OPTIC study found that significantly more patients treated with TEPEZZA (82.9%) had a meaningful improvement in proptosis (≥ 2 mm) as compared with placebo patients (9.5%) (p˂0.001) without deterioration in the fellow eye at Week 24.

Additional secondary endpoints were also met, including a change from baseline of at least one grade in diplopia (double vision) in 67.9% of patients receiving TEPEZZA compared to 28.6% of patients receiving placebo (p=0.001) at Week 24.

Horizon will conduct a post-marketing study to evaluate safety in a larger patient population. This study will also evaluate retreatment rates relative to how long patients receive the medicine.

TEPEZZA is expected to be available in the United States in the coming weeks. It is currently not registered in Australia.

As a result of the FDA approval of TEPEZZA, Horizon will make approximately $105 million in milestone payments during the first half of 2020.

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