The U.S. Food and Drug Administration (FDA) has granted Biogen’s investigational drug, litifilimab, Breakthrough Therapy Designation for the treatment of cutaneous lupus erythematosus (CLE, a chronic autoimmune skin disease). This designation is given only to therapies that show early promise for serious conditions and signals the FDA’s commitment to speeding up their development and review. This announcement marks a significant milestone for the lupus community, as there are currently no targeted treatment options for CLE on the market. 

Litifilimab (also known as BIIB059) is a first-in-class, humanized IgG1 monoclonal antibody designed to target immune cells involved in driving lupus-related inflammation. In Biogen’s Phase 2 LILAC study, participants with CLE who received litifilimab experienced reductions in skin disease activity compared to those who received a placebo. These results formed the basis for the FDA’s Breakthrough Therapy Designation, recognizing the benefits of the drug beyond current treatments, which often focus only on managing symptoms rather than addressing the disease itself.

Further research is currently underway in Biogen’s Phase 3 AMETHYST study, with data expected in 2027. The Lupus Foundation of America (LFA) has supported litifilimab trials through LFA POINT, a web-based training site designed to coordinate the training and testing for clinical instruments in the assessment of people with lupus. Continue to follow the LFA for updates on lupus drug developments. Learn more about lupus and the skin.

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