BIIB News & Events

Bioge announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for litifilimab for the treatment of cutaneous lupus erythematosus, CLE. Litifilimab is a first in-class, humanized IgG1 monoclonal antibody targeting blood dendritic cell antigen 2. CLE is a chronic autoimmune disease affecting the skin that currently has no targeted treatments. "The FDA grants breakthrough therapy designation to programs 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," said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. "This designation is a significant milestone for litifilimab as we advance the ongoing AMETHYST Phase 3 study, with the goal of bringing a new potential therapeutic option to the millions of people living with CLE."

Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted for review Eisai's Supplemental Biologics License Application, sBLA, for lecanemab-irmb subcutaneous autoinjector, SC-AI, LEQEMBI IQLIK, as a weekly starting dose. LEQEMBI is indicated for the treatment of Alzheimer's disease, AD, in patients with Mild Cognitive Impairment, MCI, or mild dementia stage of disease. The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act, PDUFA action date of May 24, 2026.