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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.
News & MeetingsNew Data from Teprotumumab Phase 3 OPTIC Study Shows Significantly Reduced Double Vision and Improved Quality of Lif...Horizon Therapeutics plc today announced...
News & MeetingsHorizon Therapeutics plc Increases Peak U.S. Annual Net Sales Expectations for Key Growth DriversHorizon Therapeutics plc announced today...
Evidence & EducationTeprotumumab for the Treatment of Active Thyroid Eye DiseaseBackground: Thyroid eye disease is a de...
News & MeetingsNew Topline TEPEZZA® (teprotumumab-trbw) Data Underscore its Efficacy in Longer Disease Duration, Long-Term Durabil...Horizon Therapeutics plc announced posit...
News & MeetingsFDA Approves First Treatment for Thyroid Eye Disease (Teprotumumab)The U.S. Food and Drug Administration (F...
News & MeetingsTeprotumumab for Treatment of Thyroid Eye Disease Meets Endpoints in Phase 3 StudyResults from the phase 3 OPTIC study sho...
News & MeetingsTEPEZZA Has Resumed Production – FAQHorizon Therapeutics, the developer of T...
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