What's Happening?
Viridian Therapeutics has announced the successful submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for veligrotug, an investigational therapy for thyroid eye disease (TED). This submission follows productive
consultations with the FDA and is supported by data from two pivotal phase 3 clinical trials, THRIVE and THRIVE-2, which demonstrated the efficacy and safety of veligrotug in treating both active and chronic TED. The therapy has shown promising results in improving symptoms such as proptosis and diplopia, and has been generally well tolerated. Veligrotug has been granted Breakthrough Therapy Designation, which supports its eligibility for Priority Review by the FDA.
Why It's Important?
The submission of the BLA for veligrotug is a significant milestone for Viridian Therapeutics, marking a step closer to providing a new treatment option for patients with thyroid eye disease, a rare and debilitating autoimmune disorder. If approved, veligrotug could become a transformative therapy, offering relief to patients suffering from the condition. The potential Priority Review could expedite the FDA's decision-making process, possibly leading to a commercial launch by mid-2026. This development also represents a key inflection point for Viridian as it transitions towards becoming a fully integrated commercial organization.
What's Next?
The FDA is expected to decide whether to accept the BLA for filing within 60 days of submission. If Priority Review is granted, the review process could be accelerated, potentially leading to a mid-2026 commercial launch of veligrotug. Viridian will continue to engage with the FDA and prepare for the potential commercialization of veligrotug, while also advancing other candidates in its pipeline for thyroid eye disease and other autoimmune conditions.
