News & Events

Tepezza (teprotumumab-trbw) Receives FDA Approval

(Originally posted January 21, 2020 and March 1, 2019)

BREAKING NEWS: The FDA has approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease. Wiley Chambers, M.D., deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research noted, “Today’s approval marks an important milestone for the treatment of thyroid eye disease. Currently, there are very limited treatment options for this potentially debilitating disease. This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non surgical treatment option.” Read more from the FDA regarding research results, adverse reactions, and the FDA’s review process.

In March 2019, Horizon Pharma released top line results for the Phase III trial of Teprotumumab, Click this link to learn more: http://bit.ly/2ECfINj

Raymond Douglas, M.D., Ph.D., the study’s co-principal investigator, director of the orbital and thyroid eye disease program at Cedars-Sinai Medical Center, and a member of the GDATF’s Physician Advisory Board stated: “In the study, patients treated with teprotumumab had an unprecedented reduction in proptosis [eye bulging], which is currently only treatable via surgery after the active disease has ended. If approved, teprotumumab would give physicians the first medicine shown to reduce proptosis during active thyroid eye disease, in addition to treating other painful symptoms.”