FDA Grants Breakthrough Therapy Designation to Biogen’s Litifilimab for Cutaneous Lupus Erythematosus

Reuters01-28

FDA Grants Breakthrough Therapy Designation to Biogen’s Litifilimab for Cutaneous Lupus Erythematosus

Biogen Inc. has announced 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 monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2). The designation is based on available data, including results from the Phase 2 LILAC study, which showed improvements in CLE skin disease activity. Biogen is currently evaluating the efficacy and safety of litifilimab in the ongoing AMETHYST Phase 3 study, with a data readout expected in 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biogen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9643964-en) on January 28, 2026, and is solely responsible for the information contained therein.

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Litifilimab is a first-in-class humanized monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2). The designation is based on available data, including results from the Phase 2 LILAC study, which showed improvements in CLE skin disease activity. Biogen is currently evaluating the efficacy and safety of litifilimab in the ongoing AMETHYST Phase 3 study, with a data readout expected in 2027.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biogen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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Litifilimab is a first-in-class humanized monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2). The designation is based on available data, including results from the Phase 2 LILAC study, which showed improvements in CLE skin disease activity. Biogen is currently evaluating the efficacy and safety of litifilimab in the ongoing AMETHYST Phase 3 study, with a data readout expected in 2027.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biogen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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