Overview
- Breakthrough Therapy Designation is intended to speed development and review of treatments for serious conditions that show promising preliminary benefit.
- Biogen said the decision drew on the totality of evidence, including the LILAC Phase 2 trial published in The New England Journal of Medicine that showed reduced skin disease activity versus placebo.
- Litifilimab is a first-in-class humanized IgG1 antibody that targets BDCA2 on plasmacytoid dendritic cells to curb type‑I interferon and other inflammatory mediators.
- The AMETHYST Phase 3 program is ongoing to evaluate efficacy and safety in cutaneous lupus, with a data readout expected in 2027.
- The therapy remains investigational with no regulatory approvals, and current care for cutaneous lupus relies on antimalarials, immunosuppressants and topical steroids that do not alter disease progression.