December 23, 2025
1 min read
Key takeaways:
- Veligrotug was assigned a Prescription Drug User Fee Act date of June 30, 2026.
- The ruling is supported by positive data from the THRIVE and THRIVE-2 trials.
The FDA granted priority review to veligrotug for the treatment of thyroid eye disease, according to a press release from Viridian Therapeutics.
Veligrotug, an anti-insulin-like growth factor-1 receptor antibody delivered intravenously, was assigned a Prescription Drug User Fee Act date of June 30, 2026, with priority review shortening the biologics license application target review timeline from 10 months to 6 months. The BLA was supported by positive data from the phase 3 THRIVE and THRIVE2 clinical trials, which met all primary and secondary endpoints.
Veligrotug was assigned a PDUFA date of June 30, 2026.
According to the release, veligrotug demonstrated a rapid onset of clinical benefit and a “statistically significant diplopia response and diplopia resolution” while generally being well tolerated.
As Healio previously reported, THRIVE randomly assigned 75 patients with active TED to treatment with veligrotug, and THRIVE-2 assigned 125 patients with chronic TED to receive the treatment.
If approved, veligrotug would act as a 12-week treatment delivered across a five-infusion treatment course, and would be the second FDA approved treatment for TED, alongside Tepezza (teprotumumab-trbw, Amgen).
“We are thrilled that the FDA granted priority review for veligrotug, marking another significant milestone for Viridian and the TED community,” Steve Mahoney, president and CEO of Viridian, said in the release. “This designation is a recognition that, if approved, veligrotug would be a significant improvement in the safety or effectiveness of treating a serious condition.”
Viridian aims to submit a marketing authorization application to the European Medicines Agency in the first quarter of 2026.
Perspective
The recent announcement of the acceptance of the BLA for veligrotug by the FDA is exciting news in the TED space.
Assuming FDA approval, this will provide an additional IGF-1R antagonist for the treatment of TED. Advantages of veligrotug compared to teprotumumab include a greater affinity for IGF-1R, the use of five infusions rather than eight, and a shorter infusion time. Efficacy and side effect profiles appear very similar between the two drugs. More data will be needed to determine the durability of veligrotug.
Veligrotug is essentially a second-generation IGF-1R antagonist, addressing some of the short-comings of the first-generation teprotumumab. Ophthalmologists will have another option to offer TED patients in active and chronic phases of the disease. The addition of veligrotug will also introduce much needed competition into the market, potentially reducing the price of the drugs and improving service to the patients and physicians.
Richard C. Allen, MD, PhD, FACS
Baylor College of Medicine
Disclosures: Allen reports consulting for Benitec Biopharma and Viatris and serving on the advisory board for Viridian Therapeutics.
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