The Food and Drug Administration’s (FDA) Arthritis Advisory Committee has recommended the approval of the 2mg, but not the 4mg dose, of baricitinib (Lilly and Incyte), to treat moderately-to-severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to methotrexate. The Committee unanimously supported the 4mg dose on efficacy grounds but found the safety and benefit-risk profile data to be inadequate.
The panel’s decision was based on four Phase 3 studies which evaluated the impact of baricitinib on RA signs and symptoms, physical function, joint damage progression and other patient-reported outcomes. The studies also evaluated the safety of baricitinib which included measures of serious infection, malignancy, major adverse cardiovascular events, venous thromboembolism, gastrointestinal perforations, and laboratory changes.
The FDA is not required to follow the Committee’s recommendations but will consider them during the baricitinib New Drug Application review. Baricitinib is a JAK inhibitor intended for use as a once-daily oral therapy. Recent research into the pathogenesis of inflammatory diseases suggests that JAK inhibitors may be useful for the treatment of a broad range of conditions.
“Baricitinib could be a promising option for rheumatoid arthritis patients in the US who are not achieving adequate disease control with currently available treatments,” said Peter Taylor, MA, PhD, professor, University of Oxford, an expert who attended the Advisory Committee meeting.