Trusted Resources: News & Meetings
Latest announcements and gatherings
FDA Approves First Treatment for Thyroid Eye Disease (Teprotumumab)
The U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). This approval represents the first drug approved for the treatment of thyroid eye disease.
The 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,” said Wiley Chambers, M.D., deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research.
Tepezza was approved based on the results of two studies (Study 1 and 2) consisting of a total of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo.
More from Teprotumumab News:
Teprotumumab Significantly Improves Proptosis in Thyroid eye Disease
Clinical Trial Analyses Substantiate that Teprotumumab Improves Debilitating Effects of TED
FDA Grants Priority Review of Teprotumumab Biologics License Application for the Treatment of TED
More from Teprotumumab Research:
Teprotumumab for the Treatment of Active Thyroid Eye Disease
(Authors: Raymond S. Douglas, George J. Kahaly et. al.)
Teprotumumab in the Treatment of Active TED: A Focus on Proptosis
(Author: Raymond S. Douglas)
myBinderRelated Content
-
Does Early Response to Intravenous Glucocorticoids Predict the Final Outcome in Patients With Moderate-To-Severe and...Purpose: Intravenous glucocorticoids (i...
-
Death by Suicide in Graves’ Disease and Graves’ Orbitopathy: A Nationwide Danish Register StudyBackground: Graves' disease (GD) is ass...
-
New Data from Teprotumumab Phase 3 OPTIC Study Shows Significantly Reduced Double Vision and Improved Quality of Lif...Horizon Therapeutics plc today announced...
-
Teprotumumab, an Insulin-Like Growth Factor-1 Receptor Antagonist Antibody, in the Treatment of Active Thyroid eye D...Thyroid eye disease is a disabling autoi...
-
A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye DiseasePrior clinical trials of TEPEZZA(TM) hav...
-
Maria Antonietta Altea, MDMaria Antonietta Altea, MD, is associate...
-
Selenium in Graves Hyperthyroidism and OrbitopathyPurpose: To review the in vitro and in ...
To improve your experience on this site, we use cookies. This includes cookies essential for the basic functioning of our website, cookies for analytics purposes, and cookies enabling us to personalize site content. By clicking on 'Accept' or any content on this site, you agree that cookies can be placed. You may adjust your browser's cookie settings to suit your preferences. More Information
The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.
Powered by
Google