FDA accepts BLA for teprotumumab, for the treatment of active thyroid eye disease

Horizon Therapeutics plc announced that the 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. The FDA has completed its filing review and determined that the application is sufficiently complete to permit a substantive review. Therefore, a priority review classification was established and the Prescription Drug User Fee Act (PDUFA) goal date is 8 March 2020.