Dec. 16, 2019: Horizon Therapeutics announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) voted collectively about the potential benefits of teprotumumab, a fully human monoclonal antibody (mAb), compensate the potential risks for the treatment of Thyroid Eye Disease (TED).
Thyroid Eye Disease is a rare, serious, progressive and vision-threatening autoimmune disease that is related with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement that can appreciably impact patient’s quality of life.
“TED can affect patients both physically and emotionally, limiting their ability in order to perform everyday activities like driving, working, reading, sleeping and participating in social activities”.
At present FDA is evaluating a Biologics License Application (BLA) for teprotumumab for the treatment of TED. https://ir.horizontherapeutics.com/news-releases/news-release-details/fda-advisory-committee-votes-unanimously-support-use
