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.
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The approval was supported by a clinical program that included dose-ranging trials (Study I and II) and confirmatory Phase 3 trials (Study III and IV).
Four Phase 3 clinical trials of baricitinib in the treatment of moderate-to-severe active rheumatoid arthritis enrolled patients who were methotrexate-naïve or had inadequate response to methotrexate, conventional disease-modifying antirheumatic drugs (DMARDs) or DMARDs with TNF inhibitors.
The NDA for baricitinib was submitted in January 2016 and a 3-month extension for time to review additional analyses was announced in January 2017.
Taylor, Peter C. et al. “Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis”