Biogen Gets FDA Breakthrough Designation for Litifilimab in CLE
By Colin Kellaher
Biogen has won U.S. Food and Drug Administration breakthrough-therapy designation for its litifilimab drug candidate for the treatment of the chronic autoimmune disease cutaneous lupus erythematosus, or CLE.
Biogen on Wednesday said litifilimab has the potential to be a first-in-class therapy targeting blood dendritic cell antigen 2 in CLE, a skin disease that currently has no targeted treatments.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug might offer substantial improvement over available therapies.
Biogen said the litifilimab designation is based on data that includes Phase 2 study results showing improvements in CLE skin- disease activity.
The Cambridge, Mass., biotechnology company said it is continuing to evaluate the efficacy and safety of litifilimab in a Phase 3 study, with a data readout expected in 2027.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 28, 2026 08:22 ET (13:22 GMT)
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