FDA accepts Horizon's thyroid eye disease BLA for priority review

Ireland-incorporated Horizon Therapeutics (Nasdaq: HZNP) saw its shares close down more than 2% at $26.54 on Monday, despite announced that the US Food and Drug Administration 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. 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 of Horizon. “The accelerated review timeline is particularly important given that there is no FDA-approved medical treatment for TED and the window of time for treatment is limited before patients experience potentially long-term, permanent damage to their eyes,” he noted.