FDA approves Lumvoa, first TED therapy labeled for both active and chronic disease

The FDA has approved Lumvoa (veligrotug-vvze), Viridian Therapeutics' treatment for thyroid eye disease (TED), the company announced. It is the first approved TED therapy with labeling that includes data for both active and chronic disease, according to Viridian.

TED is a rare, debilitating autoimmune disease marked by inflammation and tissue remodeling around and behind the eyes that can cause proptosis, diplopia, pain and vision impairment.

Lumvoa, a full antagonist of the insulin-like growth factor-1 receptor (IGF-1R), is indicated for TED regardless of disease activity or duration. It is administered over 12 weeks as five intravenous infusions given every three weeks.

Lumvoa is currently available and has a wholesale acquisition cost of $450,000 for a full course of therapy for a typical 75 kg patient, a company spokesperson told Managed Healthcare Executive. This cost is close to parity with a full course of the existing approved anti-IGF-1R therapy, Tepezza (teprotumumab-trbw). “In determining the price of Lumvoa, we considered the clinical value that Lumvoa brings to people living with TED and the healthcare system,” the spokesperson said.

Viridian officials are working closely with payers, healthcare providers, and patient advocates to support broad access to Lumvoa. “We anticipate payer coverage to take 6-9 months to reach critical mass. In the meantime, we expect Lumvoa to be accessible through the medical exception process,” the spokesperson said.

Viridian offers a $0 copay for patients with commercial insurance. The terms of the copay program say insurance companies that use accumulator or maximizer programs that prevent the assistance from counting toward a patient's deductible could lead to additional costs for the patient.

“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,” Michael Yen, M.D., professor of oculoplastic surgery and ophthalmology at Baylor College of Medicine and an investigator in the THRIVE program, 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. This is an exciting new option for physicians to offer their TED patients.”

The approval was supported by the pivotal phase 3 THRIVE and THRIVE-2 trials, which evaluated veligrotug in active and chronic TED, respectively, and which Viridian described as the two largest pivotal phase 3 trials completed in TED to date. Both met their primary and all secondary end points, demonstrating statistically significant and clinically meaningful improvements at week 15 across the key signs and symptoms of TED, the company said. Reductions in proptosis were observed as early as three weeks.

Lumvoa is the first approved TED product to show a statistically significant effect in both diplopia response and complete resolution of diplopia in active and chronic disease, according to Viridian.

In THRIVE, which enrolled patients with active TED, veligrotug produced a week 15 proptosis responder rate of 70%, compared with 5% for placebo (64% placebo-adjusted). Complete resolution of diplopia was achieved in 54% of treated patients (43% placebo-adjusted), and 64% reached a Clinical Activity Score of 0 or 1 (46% placebo-adjusted). In THRIVE-2, in patients with chronic TED (mean time since onset, 69.8 months), the proptosis responder rate was 56%, compared with 8% for placebo (48% placebo-adjusted), and 32% of treated patients achieved complete resolution of diplopia (18% placebo-adjusted).

"With the approval of Lumvoa, we take a significant step forward in providing a meaningful treatment option for people living with thyroid eye disease," Steve Mahoney, president and CEO of Viridian, said in a statement, noting it is the company's first FDA-approved medicine and first commercial product.

Labeling carries warnings for infusion reactions, exacerbation of inflammatory bowel disease, hyperglycemia, and hearing impairment, including hearing loss that may be permanent. The most common adverse reactions include muscle spasms, headache, hearing impairment, hyperglycemia and fatigue.

Viridian said it plans to launch Lumvoa immediately and has established ViridianCares, a patient support program offering access liaisons, benefit verification and financial assistance for eligible patients. The company added that its subcutaneous candidate elegrobart is on track for a biologics license application submission in the first quarter of 2027.