To announce the FDA approval of veligrotug-vvze (Lumvoa) for the treatment of thyroid eye disease (TED).
Approach:
Clinical Trials: The approval was supported by the phase 3 THRIVE trial for active TED and the phase 3 THRIVE-2 trial for chronic TED, both meeting primary and secondary endpoints at week 15.
Treatment Administration: Patients received 5 intravenous infusions every 3 weeks over a 12-week treatment course.
Patient Support Program: ViridianCares provides patient access liaisons, insurance support, benefit verification, and financial assistance for eligible patients.
Key Findings:
Reductions in proptosis were observed as early as 3 weeks after treatment initiation, according to Viridian.
Lumvoa showed statistically significant effects on diplopia response and complete resolution of diplopia, as reported in the phase 3 trials.
Interpretation:
The Lumvoa development program evaluated the drug across the full spectrum of TED, demonstrating significant improvements in patient-relevant outcomes.
Limitations:
Lumvoa carries warnings for infusion reactions, inflammatory bowel disease exacerbation, hyperglycemia, and hearing impairment, as noted in the safety information from Viridian.
Infusion reactions occurred in approximately 9% of treated patients, and hyperglycemia occurred in 12%, according to the safety data.
Conclusion:
The treatment is available immediately following FDA approval.
A posthoc analysis of a phase 2b trial found favorable changes in DNA methylation–based aging biomarkers among patients with human immunodeficiency virus–associated lipohypertrophy.
