Trusted Resources: News & Meetings
Latest announcements and gatherings
Integrated Clinical Trial Analyses Further Substantiate that Teprotumumab Significantly Improves Debilitating Effects of Thyroid Eye Disease, Including Eye Bulging, Double Vision and Quality of Life
Horizon Therapeutics plc today announced integrated, pooled efficacy data from the Phase 2 and Phase 3 clinical trials of teprotumumab for the treatment of active thyroid eye disease (TED) compared to placebo. The results support prior analyses of significant reductions in inflammation, proptosis (eye bulging) and diplopia (double vision), as well as improvements in quality of life (QoL). These data were presented at the 89th Annual Meeting of the American Thyroid Association (ATA). This is the first presentation of the pooled analyses and builds on the individual positive results of the Phase 2 and Phase 3 clinical studies.
Teprotumumab is an investigational medicine and its safety and efficacy have not been established. The teprotumumab Biologics License Application (BLA) was granted Priority Review by the U.S. Food and Drug Administration (FDA) and if approved, teprotumumab would be the first FDA-approved medicine for the treatment of active TED. The Prescription Drug User Fee Act (PDUFA) goal date is March 8, 2020.
myBinderRelated Content
-
The New England Journal of Medicine Publishes Comprehensive Data From Phase 3 Clinical Trial (OPTIC) of TEPEZZA™ (...Horizon Therapeutics plc announced that ...
-
Teprotumumab for Treatment of Thyroid Eye Disease Meets Endpoints in Phase 3 StudyResults from the phase 3 OPTIC study sho...
-
Horizon Therapeutics plc Reports Strong Third-Quarter 2019 ResultsHorizon Therapeutics plc today announced...
-
Meeting of Dermatologic and Ophthalmic Drugs Advisory Committee AnnouncementThe committee will discuss biologics lic...
-
Teprotumumab Significantly Improves Proptosis in Thyroid eye DiseasePatients with thyroid eye disease treate...
-
Breakthrough Treatment for Thyroid Eye DiseaseFor those with severe inflammation from ...
-
Comparison of treatment cost and quality-of-life impact of thyroid eye disease therapiesPurpose : Teprotumumab was approved as...
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
Facebook
Google