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January 29, 2026

FDA grants breakthrough status to Biogen’s litifilimab for CLE

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Biogen’s litifilimab (BIIB059) for cutaneous lupus erythematosus (CLE), a chronic autoimmune skin condition.

The FDA based its decision on comprehensive data, including findings from the Phase II LILAC study. Credit: Sai Thaw Kyar / Shutterstock.com.