What's Happening?
Viridian Therapeutics has submitted a Biologics License Application (BLA) to the U.S. FDA for veligrotug, a treatment for thyroid eye disease (TED). This submission follows the drug's Breakthrough Therapy Designation, which supports eligibility for Priority
Review. Veligrotug, a monoclonal antibody, has shown promising results in clinical trials, improving symptoms like proptosis and diplopia. The FDA is expected to decide on the BLA acceptance within 60 days, potentially leading to a mid-2026 commercial launch if approved.
Why It's Important?
The submission of veligrotug's BLA represents a significant milestone for Viridian Therapeutics and offers hope for patients with TED, a rare autoimmune disorder. If approved, veligrotug could become a transformative therapy, improving quality of life for those affected by TED. The drug's development highlights the potential of targeted therapies in treating rare diseases, emphasizing the importance of continued innovation in biopharmaceuticals.
What's Next?
If the FDA grants Priority Review, veligrotug could be commercially available by mid-2026. Viridian will continue to engage with the FDA and prepare for potential market launch, while also advancing other candidates in their pipeline for TED and autoimmune diseases.
