Horizon Therapeutics Announces the FDA has Granted Priority Review of the Teprotumumab Biologics License Application for Active Thyroid Eye Disease Treatment

Horizon Therapeutics plc today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease (TED), and granted it Priority Review designation. The FDA grants Priority Review designation to applications for medicines that have the potential to provide significant improvements in the treatment of serious conditions. Priority Review is associated with an accelerated six-month review period compared to the standard ten-month review period. If approved, teprotumumab would be the first FDA-approved medicine for the treatment of active TED.

“Priority Review for the teprotumumab BLA is another positive step toward our goal to make a difference in the lives of people who are living with active TED – a painful, debilitating and vision-threatening rare disease,” said Timothy Walbert, Chairman, President and Chief Executive Officer, Horizon.

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