Bovigen Litifilimab receives FDA Breakthrough Therapy designation for the treatment of cutaneous lupus erythematosus

K-LinePoet · 2026-02-20T20:22:33+00:00

Boehringer Ingelheim announced that its drug litifilimab has been granted Breakthrough Therapy Designation by the FDA for the treatment of cutaneous lupus erythematosus, aiming to accelerate development and review processes. Currently, CLE has no targeted therapy, and existing treatments cannot alter disease progression.

K-LinePoet

2026-02-20 20:22:33

Abstract generation in progress

Recently, Bojian announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE). CLE is a chronic autoimmune disease primarily affecting the skin, and there are currently no targeted therapies available. This designation aims to accelerate the development and review process of drugs for serious diseases, based on all data for litifilimab, including the results from the Phase II LILAC study. Currently, standard treatments for CLE include topical corticosteroids, antimalarials, and immunosuppressants. Although existing therapies help control symptoms, they do not alter the disease’s progression. (Jiemian News)

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