Next-Generation IGF-1R Inhibitor Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has granted final approval for Lumvoa (veligrotug-vvze) from Viridian Therapeutics for the treatment of Thyroid Eye Disease (TED). Lumvoa is a full antagonist monoclonal antibody that targets the insulin-like growth factor-1 receptor (IGF-1R). This approval is noteworthy as it encompasses a broad indication for both active and chronic TED patients. It overcomes the limitations of existing standard treatments, which primarily focused on early-stage active patients, and provides a new treatment option for all patients regardless of the stage or duration of the disease.

Efficacy and Convenience Demonstrated Through Phase 3 Clinical Data

This approval is based on data from the THRIVE Phase 3 trial in active patients and the THRIVE-2 Phase 3 trial in chronic patients. In the THRIVE trial, the Lumvoa treatment group demonstrated a 70% proptosis responder rate at week 15, a significant improvement compared to 5% in the control group. The THRIVE-2 trial, which involved chronic patients, also achieved a statistically significant reduction in mean proptosis of 2.34mm and a 56% improvement in diplopia compared to the control group. Notably, Lumvoa reduces the treatment period by half, requiring only five infusions over 12 weeks, compared to the 8 infusions over 24 weeks required for existing treatments, significantly improving patient convenience.

Market Dynamics Shift with New Competition

This approval introduces a strong competitor to the TED treatment market, which was previously dominated by Amgen's Tepezza (teprotumumab-trbw). Tepezza currently generates approximately $1.9 billion in annual revenue. However, its long treatment duration and infusion time of 60-90 minutes have been inconvenient for patients. Lumvoa, with its reduced number of infusions (5) and shorter infusion time (30-45 minutes), is expected to rapidly gain market share. By emphasizing its clear differentiators of patient convenience and shorter treatment duration, Viridian aims to secure a dominant position in the TED market, which is estimated to be worth over $2.5 billion annually.

Monitoring Adverse Reactions and Future Prospects of Subcutaneous Formulation

However, the risk of hearing impairment, a known adverse effect associated with IGF-1R targeted therapies, remains a key concern. In the THRIVE-2 trial, the incidence of hearing impairment in the Lumvoa group was 12.8%, compared to 3.2% in the placebo group, necessitating regular hearing tests during treatment. Viridian is not only satisfied with the approval of the intravenous (IV) formulation but is also accelerating the development of elegrobart, a subcutaneous formulation designed to maximize ease of administration. The company plans to complete the Biologics License Application (BLA) submission for the subcutaneous formulation in the first quarter of 2027. If successful in expanding into the self-administered market, Viridian's long-term market competitiveness will be further strengthened.