Michel Farnier.

In a post hoc protection analysis, the rate of major adverse cardiovascular events was 48 percent lower among patients who received alirocumab than among those who received placebo during the 80 weeks of follow-up . When all adjudicated cardiovascular occasions were included , the difference between groups had not been significant. Several limitations of the analysis ought to be noted. First, although the ODYSSEY LONG TERM trial followed sufferers receiving study-medication therapy for a longer period than most other trials of PCSK9 inhibitors, the duration of follow-up is relatively brief for a treatment for a persistent disease still, and longer-term research will be required. Second, the usefulness of the neurocognitive findings is limited by the lack of formal neurocognitive testing as part of the study style.Leonard, M.D., senior vice president, Global Pharmaceutical Research and Advancement, Abbott. This approval underscores Abbott’s commitment to investing in and advancing our pipeline to advantage individuals with IBD. About the HUMIRA UC Phase 3 Clinical Program Abbott’s submission for HUMIRA was backed by results from two phase 3 research, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled adult sufferers who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants .