Biogen’s litifilimab has received Breakthrough Therapy Designation from the US FDA to treat cutaneous lupus erythematosus (CLE).
CLE is a chronic autoimmune skin disorder characterised by symptoms such as rash, pain, itch and photosensitivity. CLE patients also often experience skin damage that leads to scarring, alopecia and dyspigmentation, significantly affecting quality of life.
Around 90% of lupus patients are women, and symptoms typically begin from aged 15 to 40. Lupus has a disproportionately high impact on certain ethno-racial groups, such as African American, Asian and Hispanic/Latino communities.
There is currently no cure for lupus. Standard of care therapies for CLE include topical steroids, antimalarials and immunosuppressants, but these treatments manage symptoms rather than slowing or preventing disease progression.
Victoria Werth, professor of dermatology at the Perelman School of Medicine, University of Pennsylvania, said: “With topical steroids and antimalarials as the initial therapies for managing CLE and no alternatives specifically approved for CLE, there is a need for effective, targeted treatments, and that could be a drug like litifilimab.”
The FDA grants Breakthrough Therapy Designation to treatments for serious conditions so that their development and possible approval can be accelerated. The granting of this designation to litifilimab is based on a variety of data, including data from the phase 2 LILAC study. Data from the study was published in The New England Journal of Medicine and showed reductions in CLE disease activity in patients receiving litifilimab, compared to patients receiving placebo.
Litifilimab is a humanised IgG1 monoclonal antibody designed to target blood dendritic cell antigen 2 (BDCA2). Its safety and efficacy are being evaluated in the ongoing phase 3 AMETHYST study. Data from this study is expected to be released in 2027.
Priya Singhal, executive vice president and head of development at Biogen, said: “This designation is a significant milestone for litifilimab as we advance the ongoing AMETHYST phase 3 study, with the goal of bringing a new potential therapeutic option to the millions of people living with CLE.”