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US FDA panel unanimously backs Horizon's drug for autoimmune eye disease

A panel of advisers to the U.S. Food and Drug Administration has voted unanimously to approve Horizon Therapeutics PLC's experimental treatment for a certain autoimmune eye disorder.

During a Dec. 13 meeting, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 12 to 0 that the benefits of Horizon's drug candidate, teprotumumab for thyroid eye disease, outweighed its risks.

Thyroid eye disease, common in people with hyperthyroidism or Graves' disease, leads to bulging and misalignment of the eyes, blurred or double vision and sometimes blindness.

The drug is slated to receive a decision from the FDA, which is not required to adhere to the panel's recommendation, by March 8, 2020. The agency granted the drug priority review, orphan drug, fast track and breakthrough therapy designations, which provide incentives to speed up the regulatory process.

Teprotumumab is a monoclonal antibody, meaning it is derived from identical immune cells to target a specific antigen. Teprotumumab targets the insulin-like growth factor 1 receptor, or IGF-1R, which is overexpressed in thyroid eye disease, causing inflammation and tissue expansion behind the eyes.

In clinical trials, teprotumumab reduced bulging of the eyes in treated patients and was effective for almost a year after therapy.

Shares of Horizon were halted while the commission met to consider the therapy.