WALTHAM, Mass.—Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company, announced that the Food and Drug Administration (FDA) has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED). 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. “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 CEO of Viridian.
He continued, “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.”
Viridian said it plans to launch Lumvoa immediately. The company 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 to help eligible patients and their caregivers navigate the treatment journey and receive therapy as prescribed.
“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, MD, 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.”
