Horizon Therapeutics plc today announced an integrated analysis of efficacy data from the Phase 2 and Phase 3 clinical trials of teprotumumab will be presented during an oral session at the American College of Rheumatology (ACR) Annual Meeting, Nov. 8-13 in Atlanta. The U.S. Food and Drug Administration is currently evaluating under Priority Review a Biologics License Application (BLA) for teprotumumab in the treatment of active thyroid eye disease (TED). If approved, teprotumumab would be the first FDA-approved medicine for active TED. The Prescription Drug User Fee Act (PDUFA) goal date is March 8, 2020. Teprotumumab is an investigational medicine and its safety and efficacy have not been established.
Presentation Details:
Oral Presentation: Teprotumumab, A Novel Biologic for Active Thyroid Eye Disease (abstract 1807)
Speaker: Raymond Douglas, MD, PhD, Director of the Orbital and Thyroid Eye Disease Program at Cedars-Sinai Medical Center
Date: Monday, November 4, 2019
Time: 2:45-3:00 PM ET
The event has ended.
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