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Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options

Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous lupus erythematosus (CLE) skin disease activityLitifilimab has the potential to be a first-in-class therapy targeting blood dendritic cell antigen 2 (BDCA2) in CLE, a chronic autoimmune skin disease that has a substantial impact on the daily life of patients, and may result in permanent scarring and disfigurementFDA Breakthrough Therapy Designation is

articleBiogen Inc.January 28, 202611/company/biogen-inc/news/biogen-litifilimab-receives-fda-breakthrough-123000526
Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options

About this update from Biogen Inc.

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cutaneous lupus erythematosusskin diseaseBiogenautoimmune skin diseasesystemic lupus erythematosusLupus Research Alliancedendritic cellCLEclinical trialsFDABreakthrough Therapy