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Viridian Therapeutics Receives FDA Breakthrough Therapy Designation for Veligrotug for the Treatment of Thyroid Eye Disease (TED)
- Breakthrough Therapy Designation request based on veligrotug’s (i) consistent and robust...
About this update from Viridian Metals Inc
[{"type":"text","content":"Viridian Therapeutics Receives FDA Breakthrough Therapy Designation for Veligrotug for the Treatment of Thyroid Eye Disease (TED)\n\n\n .bwalignc { text-align: center; list-style-position: inside }\n.bwuline { text-decoration: underline }\n \n\n\n\n\n - Breakthrough Therapy Designation request based on veligrotug’s (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response -\n \n\n\n\n - Veligrotug met all of its primary and secondary endpoints in the pivotal THRIVE and THRIVE-2 clinical trials in active and chronic TED -\n \n\n\n\n - First and only drug candidate in chronic TED to demonstrate statistically significant and clinically meaningful improvement and resolution of diplopia in a global phase 3 clinical trial -\n \n\n\n\n - Breakthrough Therapy Designation supports eligibility for Priority Review -\n \n\n\n\n - Biologics License Application (BLA) submission for veligrotug on track for second half 2025 with a planned U.S. launch in 2026, if approved -\n \n\n\n\n\n Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to veligrotug (“veli”), the company’s lead anti-insulin-like growth factor-1 receptor (IGF-1R) drug candidate for the treatment of TED.\n \n\n Breakthrough Therapy Designation is reserved for drug candidates intended to treat serious or life-threatening conditions that address an unmet need where clinical evidence has indicated they may demonstrate substantial improvement on a clinically significant endpoint over existing therapies.\n \n\n “The FDA’s decision to grant veli Breakthrough Therapy Designation underscores that veli may offer substantial improvement over existing therapies, and we believe it reinforces veli’s potential to be a differentiated, treatment-of-choice for patients living with TED,” said Steve Mahoney, Viridian’s President and CEO. “Veli is the only therapy that has demonstrated statistically significant and clinically meaningful improvement and resolution of diplopia in both active and chronic TED. Veli al...