Baricitinib Gets Fast Track Status for Systemic Lupus Erythematosus

Eli Lilly and Incyte announced that the Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib for the treatment of systemic lupus erythematosus (SLE). 

Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year. In this randomized, placebo-controlled, trial, patients were assigned to baricitinib 2mg (N=105), baricitinib 4mg (N=104), or placebo (N=105) for 24 weeks. The baricitinib 4mg dose significantly improved the signs and symptoms of active SLE (as measured by Systemic Lupus Erythematosus Disease Activity Index-2000) in patients who were not adequately controlled despite standard of care therapy.

Currently, 2 doses of baricitinib are being evaluated in Phase 3 SLE trials. The drug is also being studied as a potential treatment for moderate to severe atopic dermatitis; Phase 3 data are anticipated to be announced in the first half of 2019. 

Baricitinib (Olumiant), an oral Janus kinase (JAK) inhibitor, is currently indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more tumor necrosis factor (TNF) antagonist therapies. 

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