FDA clears Viridian's Tepezza rival for thyroid eye disease
Viridian Therapeutics has fired a shot across Amgen's bows with FDA approval of Lumvoa, the first direct rival to Amgen's thyroid eye disease (TED) therapy Tepezza.
Waltham, Massachusetts-based Viridian said that Lumvoa (veligrotug) is the first treatment for TED with a label that includes both active and chronic stages, as it sets off in pursuit of Tepezza (teprotumumab), which made $1.9 billion in global sales last year and – until now – was the only FDA-approved treatment for the disease.
Tepezza has been used mainly for active disease since its first approval in 2020, although it's worth noting that its label was extended in 2023 to include patients "regardless of disease activity or duration."
Lumvoa arrives on the market with a faster intravenous dosing regimen compared to Tepezza, although Amgen already has phase 3 results in hand for a new, subcutaneous formulation, delivered using an on-body injector (OBI) device, that could represent a step up in patient convenience. Both drugs have the same general mechanism, acting as IGF-1 inhibitors.
Viridian is losing no time in launching its first commercial product, saying it will be available immediately, and has set the pricing of the drug in line with Tepezza at around $150,000 for a six-month course. It is also developing a subcutaneous alternative, elegrobart, and is hoping to be ready to file that in the US early next year.
TED is a rare autoimmune disorder in which the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards in a condition known as proptosis, with accompanying visual disturbances like double vision (diplopia) as well as pain, redness, and swelling.
The active form of the disease is marked by acute inflammation and pain that can last for months to years, while its chronic form is a stable phase in which symptoms persist without active swelling.
"Lumvoa is 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," said Viridian in a statement. The company has indicated that it sees the best potential in addressing as-yet untreated TED patients in the US, rather than trying to switch patients from Amgen's drug.
Christine Gustafson, chief executive of the TED Community Organisation, welcomed the approval, noting that TED "can be physically painful and emotionally exhausting, and patients experience the disease as highly disruptive to their daily lives" and that additional treatment options are needed.
There was disappointment on that front in April when Immunovant reported disappointing phase 3 results with its TED candidate, FcRn blocker batoclimab, in TED.
