Posted by Michael Wonder on 11 Jul 2019
Horizon Therapeutics submits teprotumumab biologics license application for the treatment of active thyroid eye disease
10 July 2019 - Horizon Therapeutics announced today that it has submitted a biologics license application to the U.S. FDA for its investigational medicine teprotumumab for the treatment of active thyroid eye disease.
Teprotumumab has breakthrough therapy, orphan drug and fast track designations from the FDA.
Horizon requested priority review for the application, which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing.
The teprotumumab submission includes results from the Phase 3 confirmatory clinical trial, called OPTIC (Treatment of Graves’ Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study), as well as positive Phase 2 results.
