FDA Approves Veligrotug for Active and Chronic Thyroid Eye Disease

The U.S. Food and Drug Administration has approved Lumvoa for the treatment of thyroid eye disease (TED), irrespective of disease activity or duration, according to an announcement by Viridian Therapeutics⁠. Veligrotug is the first therapy approved with labeling that covers both active and chronic forms of TED. Clinical trials demonstrated statistically significant improvements in diplopia (double vision), including both response rates and complete resolution, in patients with active as well as chronic disease. This approval expands treatment options for individuals across the full spectrum of thyroid eye disease.

“With the approval of Lumvoa, we take a significant step forward in providing a meaningful treatment option for people living with thyroid eye disease,” said Steve Mahoney, President and Chief Executive Officer of Viridian. “Lumvoa was designed with patient needs at the forefront and is Viridian’s first FDA-approved medicine and our first commercial product. This marks an important milestone for us and reflects years of focused execution by the Viridian cross-functional teams. Our commercial and medical affairs teams have been preparing for this moment for a long time, and in particular since receiving Breakthrough Therapy Designation last year. We are ready to support patients and physicians from day one.”

“The Lumvoa development program was a robust evaluation of the drug across the full spectrum of TED, including both active and chronic disease, showing significant improvements in outcomes that matter to patients and clinicians,” said Michael Yen, M.D., Professor of Oculoplastic Surgery and Ophthalmology at Baylor College of Medicine and an investigator in the THRIVE program. “It’s encouraging to see a new treatment for the full spectrum of the disease with data showing rapid onset of proptosis reduction as well as improvements in diplopia. This is an exciting new option for physicians to offer their TED patients.”

“The TED community is pleased to see this important advancement in the treatment of TED. TED can be physically painful and emotionally exhausting, and patients experience the disease as highly disruptive to their daily lives,” said Christine Gustafson, Founder, Chief Executive Officer, and Executive Director, TED Community Organization. “Having a new treatment available could be very important for the many patients who are seeking help for thyroid eye disease.”

Immediate Launch of Lumvoa Supported by Comprehensive Patient Support Program

Viridian plans to launch Lumvoa immediately, and physicians can prescribe Lumvoa tomorrow. Viridian has worked closely with payers, healthcare providers, and patient advocates to support broad access to Lumvoa. As part of this commitment, Viridian has created ViridianCares™, a comprehensive patient support program that provides dedicated patient access liaisons, insurance coverage support and benefit verification, and financial assistance programs for eligible patients, to help patients and caregivers navigate the treatment journey and receive therapy as prescribed. For more information on ViridianCares, call 866-VCARES1 (866-822-7371).

Approval Supported by Pivotal THRIVE and THRIVE-2 Clinical Trials

Lumvoa was approved by the FDA under Priority Review and supported by the THRIVE (active TED) and THRIVE-2 (chronic TED) pivotal phase 3 clinical trials. Lumvoa is a full antagonist of IGF-1R and the first approved treatment for TED with labeling that includes data for both active and chronic TED. Both the THRIVE and THRIVE-2 clinical trials met their respective primary and all secondary endpoints, consistently demonstrating statistically significant and clinically meaningful improvements at week 15 across all of the key signs and symptoms of TED.

Across both clinical trials, patients received a 12-week course of Lumvoa designed to reduce the burden of treatment. Lumvoa demonstrated a rapid onset of clinical benefit, with reductions in proptosis observed as early as three weeks. Lumvoa is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution in active and chronic TED. Lumvoa was granted Breakthrough Therapy Designation and Priority Review by the FDA.