Biotechnology company Biogen Inc (Nasdaq:BIIB) announced on Wednesday that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) to treat cutaneous lupus erythematosus (CLE).

CLE is a chronic autoimmune skin disease that can lead to permanent scarring and disfigurement. There are currently no targeted treatments for CLE.

Litifilimab is a first-in-class humanised IgG1 monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2). The designation is based on cumulative data, including the Phase 2 LILAC study, which showed improvements in CLE skin disease activity compared with placebo.

Breakthrough Therapy Designation is intended to expedite development and review of therapies for serious conditions. Current CLE treatments, including topical steroids, antimalarials, and immunosuppressants, manage symptoms but do not alter disease progression. Biogen is continuing evaluation of litifilimab in the AMETHYST Phase 3 study, with results expected in 2027.

Litifilimab has the potential to be a first-in-class therapy offering a new targeted option for patients with CLE.