TEPEZZA's FDA approval (2020)
Horizon Therapeutics' teprotumumab (TEPEZZA) became the first drug approved for thyroid eye disease, ending a roughly 70-year stretch with no approved treatment. The FDA cleared it for active TED based on trials showing significant proptosis reduction.
TEPEZZA became the standard of care for active TED in the US, with rapid uptake despite high cost.
It validated IGF-1R blockade as a therapeutic mechanism in TED and set the efficacy benchmark that later drugs, including SYCUME, are measured against.
SYCUME is the second IGF-1R antibody approved worldwide, and RESTORE-3's results were compared directly against TEPEZZA's data in inactive TED.
