Horizon announced it will submit an application for a biologics license mid-year to the U.S. Food and Drug Administration for its proposed treatment of the thyroid eye disease. The company will also revealed detailed data later this year to a peer-reviewed journal and to a medical conference.
If the FDA approves teprotumumab, Horizon’s new drug would be the first on the market to treat TED, a rare eye disease that afflicts as many as 20,000 people each year in the U.S.
A “progressive, debilitating autoimmune disease,” TED can cause eye bulging, misalignment of the eyes, double vision and, in some cases, blindness, according to Horizon.
“The dramatic results of the teprotumumab Phase 3 confirmatory trial … form a highly convincing body of clinical evidence supporting teprotumumab for the treatment of active thyroid eye disease,” Timothy Walbert, chairman, president and CEO of Horizon, said in a note. “This is a key milestone as we evolve into a research-focused company.”
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