Posted by Michael Wonder on 10 Sep 2019
Horizon Therapeutics announces the FDA has granted priority review of the teprotumumab biologics license application for the treatment of active thyroid eye disease
9 September 2019 - If approved, teprotumumab would be the first FDA approved medicine for this vision-threatening disease.
Horizon Therapeutics today announced that the U.S. FDA has accepted the biologics license application for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease, and granted it priority review designation.
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 goal date is 8 March 2020.
