FDA Advisory Committee Recommends Against Approval of Baricitinib at Higher Dose for RA

The US Food and Drug Administration (FDA) Arthritis Advisory Committee has recommended approval of the 2 mg dose of baricitinib, a once-daily oral medication for adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to methotrexate. However, the advisory committee did not recommend approval of the 4 mg dose of baricitinib based on the adequacy of the safety and benefit-risk profiles.

The FDA advisory committee supported the assessment that the baricitinib data provided substantial evidence of efficacy at both doses. The committee also voted in favor of the assessment that the data adequately supported the approval of the 2 mg dose, but voted against the assessment that the safety data was adequate to support the approval of the 4 mg dose based on the proposed indication.

“Despite advances in the management of RA over the last 20 years, which include early treatment, optimized use of traditional therapies for rheumatic disease and the advent of newer medications such as biologics, many patients are still struggling to meet treatment targets, and live with debilitating pain, fatigue and other symptoms of RA,” stated Peter Taylor, MA, PhD, professor at the University of Oxford, an expert who attended the Advisory Committee Meeting. “Baricitinib could be a promising option for RA patients in the US who are not achieving adequate disease control with currently available treatments.”

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The committee’s recommendation was based on data from baricitinib’s global development program, which encompassed 4 completed phase 3 studies and included 3492 patients with a range of treatment experiences. The studies evaluated baricitinib’s treatment effects related to signs and symptoms of RA, physical function, joint damage progression and other patient-reported outcomes. The program also evaluated risk factors for patients with RA, including serious infection, malignancy, major adverse cardiovascular events, venous thromboembolism, gastrointestinal perforations, and key laboratory changes. The safety profile of baricitinib included 7860 patient-years of exposure.

The FDA is not required to follow the recommendation of the advisory committee, but will consider it during the review of the new drug application for baricitinib.


FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis [press release]. Indianapolis, Indiana: Eli Lilly and Company. Published April 23, 2018. Accessed April 24, 2018.