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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 improvement and resolution of diplopia in chronic TED, and (ii)
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"\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- 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- 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- Breakthrough Therapy Designation supports eligibility for Priority Review -\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 WALTHAM, Mass.--(BUSINESS WIRE)--\nViridian 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\nBreakthrough 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“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 also showed a rapid onset of treatment effect, including an improvement in proptosis response in as few as three weeks after just one infusion. We believe veli will be an important potential new treatment option for patients living with TED, including whose disease is unaddressed by existing therapies. We continue to execute on our pl...