Posted by Michael Wonder on 28 Jan 2026
Biogen’s litifilimab receives FDA breakthrough therapy designation for cutaneous lupus erythematosus, a disease with no targeted treatment options
28 January 2026 - Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous lupus erythematosus skin disease activity.
Biogen announced today that the US FDA has granted breakthrough therapy designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus.
