Viridian Therapeutics, Inc., has received FDA approval for Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED).
And, with this approval, the company also announced plans for an immediate U.S. commercial launch—but more on that in a moment.
First thing’s first: Let’s get a look at this therapy.
Lumvoa is formulated as an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody formulated to:
- Block cell surface receptor activity
- Target antibody and protein engineering for specific diseases, such as TED
For more on this: Check out why IGF-1Rs are clinically-validated targets for TED.
And its official indication?
The therapeutic is indicated for the treatment of TED—regardless of TED activity or duration.
So how, exactly, does it treat TED?
By reducing TED-associated tissue swelling and inflammation via five intravenous (IV) infusions of 10 mg/kg administered 3 weeks apart.
The idea: for TED patients to complete treatment in 12 weeks.
Talk more about this dosing.
Per Lumvoa’s prescribing information (PI), the therapeutic’s diluted solution is administered over 45 minutes for the first infusion.
- If well tolerated, subsequent infusions are administered over a minimum of 30 minutes.
- If not well tolerated, subsequent infusions continue to be administered over a minimum of 45 minutes.
The dosage form and strength: 500 mg/mL (50 mg/mL) solution in a single-dose vial.
Now give me a quick review of the supporting data for the approval.
That would be positive results from two pivotal phase 3 clinical trials:
- THRIVE (NCT05176639)
- The data: See here for positive topline (15-week) and click here for 52-week results.
- THRIVE-2 (NCT06021054)
- The data: Positive 15-week topline can be found here.
Across both studies: Veli was found to be generally well tolerated, met all primary and secondary endpoints as well as demonstrated “a rapid onset of clinical benefit and statistically significant and meaningful effect on multiple diplopia endpoints.”
Any adverse events to report?
Among some of the most common (occurring in ≥5% of patients):
- Muscle spasms
- Headache
- Hearing impairment
- Hyperglycemia
- Fatigue
- Diarrhea
- Ear discomfort
- Infusion-related reaction
Also worth noting: An estimated 29% (24/82) of menstruating women treated with Lumvoa were reported to experience menstrual disorders (amenorrhea, menstruation irregularity, dysmenorrhea, menstruation delayed, and intermenstrual bleeding).
- Compare this to just 6% (2/33) of patients treated with placebo in the clinical trials.
And keeping with the theme … any warnings, precautions, and contraindications?
Per Lumvoa’s PI, there are no contraindications.
However, there are definitely a few warnings and precautions for patients to consider when receiving IV infusions (with some overlap to the clinical trials’ adverse reactions):
- Infusion reactions
- Inflammatory bowel disease (IBD)
- Hyperglycemia
- Hearing impairment (including hearing loss)
Duly noted. So what do we know about commercial launch plans?
Those are actually already in motion. In fact, Viridian said it “plans to launch Lumvoa immediately.”
In fact, the company has created a comprehensive patient support program called ViridianCares to offer (for eligible patients):
- Dedicated patient access liaisons
- Insurance coverage support and benefit verification
- Financial assistance programs
Eyecare providers and patients interested in learning more about these benefits are asked to call 866-VCARES1 (866-822-7371).
And what’s the big-picture significance of this approval?
Lumvoa is now the second FDA-approved treatment for TED (following Amgen’s Tepezza [teprotumumab-trbw], which was approved in 2020).
Hold up—how do these treatments differ?
One major distinction: Lumvoa is noted as the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution of diplopia in active and chronic disease.
Nice! Last question: Any update on Viridan’s other TED therapy in the works?
That investigational therapeutic is currently on track for a H1 2027 BLA submission.
For a refresh: Check out last month’s positive topline phase 3 data.
- The potential for it: To become the first subcutaneous autoinjector for TED.