Viridian Therapeutics has received US FDA approval for Lumvoa (veligrotug-vvze) for thyroid eye disease, marking the first treatment authorised with labelling that includes data for both active and chronic forms of the condition.
TED is a rare autoimmune disease that causes inflammation and tissue changes around the eyes, leading to proptosis, diplopia, pain and impaired vision.
Steve Mahoney, President and Chief Executive Officer of Viridian, said: “With the approval of Lumvoa, we take a significant step forward in providing a meaningful treatment option for people living with thyroid eye disease.”
He said: “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.”
He added: “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.”
Michael Yen, Professor of Oculoplastic Surgery and Ophthalmology at Baylor College of Medicine, said: “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.”
He said: “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.”
Christine Gustafson, Chief Executive Officer of the TED Community Organization, said: “The TED community is pleased to see this important advancement in the treatment of TED.”
She said: “TED can be physically painful and emotionally exhausting, and patients experience the disease as highly disruptive to their daily lives.”
Lumvoa will be launched immediately, supported by ViridianCares, a patient access programme offering insurance support, benefit verification and financial assistance for eligible patients.
Approval was based on the pivotal THRIVE and THRIVE-2 phase 3 trials, which met all primary and secondary endpoints.
Lumvoa showed rapid clinical benefit, including reductions in proptosis as early as three weeks, and is the first approved product for TED to demonstrate a statistically significant effect in both diplopia response and complete resolution in active and chronic disease.
