The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Biogen’s litifilimab (BIIB059) for cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition. Results from this trial indicated that litifilimab reduced skin disease activity in patients with CLE compared to placebo. It is being investigated for both CLE and systemic lupus erythematosus (SLE). Biogen development executive vice-president and head Priya Singhal said: “The FDA grants breakthrough therapy designation to programmes based on the seriousness of the condition and the potential of the therapeutic candidate to provide substantial improvements over available therapies. “The FDA’s designation reinforces Biogen’s belief that litifilimab could be a first-in-class therapy targeting BDCA2 for cutaneous lupus erythematosus.