Biogen Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE). Litifilimab is a first-in-class humanized monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2). The designation is based on available data, including results from the Phase 2 LILAC study, which showed improvements in CLE skin disease activity. Biogen is currently evaluating the efficacy and safety of litifilimab in the ongoing AMETHYST Phase 3 study, with a data readout expected in 2027.

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