Key takeaways:
- The FDA granted breakthrough remedy designation to veligrotug.
- Veligrotug demonstrated fast discount and backbone of diplopia in two section 3 trials.
Editor’s be aware: It is a growing information story. Please examine again quickly for updates.
Viridian Therapeutics acquired breakthrough remedy designation from the FDA for veligrotug for the therapy of thyroid eye illness, in response to a press launch.
Veligrotug, also referred to as veli and VRDN-001, is an anti-insulin-like progress factor-1 receptor antibody delivered intravenously for thyroid eye illness (TED). Veli met the first and secondary endpoints within the THRIVE and THRIVE-2 pivotal section 3 scientific trials and demonstrated fast discount and backbone of diplopia in each trials, in response to the discharge.
“Veli is the one remedy that has demonstrated statistically vital and clinically significant enchancment and backbone of diplopia in each energetic and power TED,” Viridian president and CEO Steve Mahoney mentioned within the launch. “Veli additionally confirmed a fast onset of therapy impact, together with an enchancment in proptosis response in as few as 3 weeks after only one infusion. We imagine veli will likely be an necessary potential new therapy possibility for sufferers dwelling with TED, together with whose illness is unaddressed by current therapies. We proceed to execute on our deliberate [biologics license application] submission within the second half of 2025 and are excited that this designation helps eligibility for precedence overview as we put together for our deliberate U.S. industrial launch in 2026.”
The corporate mentioned if veligrotug is accepted, it might additionally assist the introduction of VRDN-003, its subcutaneous TED remedy.
