Horizon Grabs Priority Review for Active Thyroid Eye Disease Biologic

September 18, 2019

The FDA has granted Horizon Therapeutics priority review designation for its biologic application for teprotumumab, an investigational drug for treating active thyroid eye disease (TED).

Active TED is an autoimmune inflammatory disorder that lasts about one year for nonsmokers and can involve eyelid retraction, eyelid swelling, problems closing the eye, redness, tearing from dryness and other issues.

Teprotumumab, a human monoclonal antibody being developed by Horizon Therapeutics, would be the first treatment for active TED to be approved. The agency said it will hold an advisory committee meeting to discuss the application.

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