Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options

2026-01-28 - 12:40

CAMBRIDGE, Mass., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced today 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 IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2). CLE is a chronic autoimmune disease affecting the skin that currently has no targeted treatments. Read More