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Horizon Therapeutics' eye disease treatment accepted for US FDA priority review

Horizon Therapeutics PLC said the U.S. Food and Drug Administration will expedite the review process of its medicine teprotumumab to treat an autoimmune eye disease.

The Irish biopharmaceutical company said the FDA has accepted its biologics license application and granted priority review to teprotumumab to treat patients with active thyroid eye disease. The regulator is expected to make a decision on the medicine by March 8, 2020.

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Active thyroid eye disease is a progressive, debilitating disorder with a limited window for treatment without surgical intervention. It is characterized by the inflammation of eye muscles, eyelids, tear glands and tissues behind the eye.

If the application is approved, teprotumumab would become the first FDA-approved medicine to treat active thyroid eye disease, the company said in a Sept. 9 press release. Teprotumumab has received the breakthrough-therapy, orphan-drug and fast-track designations in the U.S.

Horizon's application is based on the results of phase 2 and 3 trials. The drug reduced bulging of the eye in 82.9% of patients treated compared to 9.5% of patients receiving a placebo during a late-stage study called Optic. Teprotumumab also maintained its effectiveness in patients for nearly a year after therapy.