The committee recommends the approval of baricitinib 2-mg, but not 4-mg; this comes a year after baricitinib was rejected by the FDA.
The US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended the approval of Eli Lilly’s baricitinib 2-mg dose, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis for adult patients who had an inadequate response or intolerance to methotrexate.
The committee however, unanimously supported the efficacy of the 4-mg dose but did not recommend the higher dose for approval, voting 10—5 for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
The vote comes a year after baricitinib was rejected by the FDA, which cited serious safety concerns.
“We are confident that baricitinib, if approved, can help people in the US manage the challenges of living with rheumatoid arthritis,” Christi Shaw, president, Lilly Bio-Medicine, said in a statement. “While we are disappointed with the Advisory Committee’s assessment of the data for the 4-mg dose, we are confident in the positive benefit-risk profile of both the 2-mg and 4-mg doses. We look forward to continuing our work with the FDA on our New Drug Application (NDA) and are hopeful that baricitinib will receive approval in the coming months.”
In both of the doses, the advisory committee voted to support the assessment based on the substantial evidence of efficacy data provided.
For the 2-mg dose, the committee voted in favor of the assessment that the drug’s safety data adequately support its approval, however, for the 4-mg dose, the committee voted against the assessment that the safety data was adequate to support its approval based on the proposed indication.
The recommendation was based on the drug’s global development program, which included 4 completed phase 3 studies that studied 3492 patients who represented a range of treatment experiences.
The studies evaluated baricitinib’s treatment impact related to signs and symptoms, physical function, joint damage progression and other patient-related outcomes of rheumatoid arthritis.
Additionally, the program evaluated recognized risks of patients including serious infection, malignancy, major adverse cardiovascular events, venous thromboembolism and gastrointestinal perforations, along with key laboratory changes. The safety profile is based on 7860 patient-years of exposure.
Baricitinib, a once-daily oral JAK inhibitor, is currently in clinical studies for inflammatory and autoimmune diseases. The 2-mg and 4-mg doses of baricitinib are currently approved in more than 40 countries including member states of the European Union and Japan.