FDA Delays Approval of JAK Inhibitor Baricitinib
The FDA requested more clinical data to establish appropriate doses and safety issues.
Eli Lilly and Incyte announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of baricitinib for the treatment of moderate-to-severe rheumatoid arthritis (RA).
The FDA's letter states that the NDA cannot be approved in its current form. The FDA specified that more clinical data are needed to establish the most appropriate doses and to better characterize the safety issues across the treatment groups. The resubmission timeline will depend on additional discussions with the FDA.
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. The NDA included data from Phase 3 trials of baricitinib in patients with moderate-to-severe active RA where some included pre-specified comparisons to approved DMARD agents: methotrexate and adalimumab.
Baricitinib is an investigational oral JAK inhibitor evaluated in studies for inflammatory and autoimmune diseases. JAK-dependent cytokines have been associated with the pathogenesis of several inflammatory and autoimmune diseases, suggesting possible efficacy in RA.
Baricitinib is also being investigated in Phase 2 trials for atopic dermatitis and systemic lupus erythematosus, and a Phase 3 trial for psoriatic arthritis anticipated for later this year.
U.S. FDA issues complete response letter for baricitinib [press release]. Indianapolis, IN: Eli Lilly & Co. Published online April 14, 2017. Accessed April 18, 2017.