Victoza’s Non-Cardio Safety May Dominate At FDA Panel Review
US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.
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US FDA apparently agreed with some of its advisory committee members that liraglutide should be approved for cardiovascular risk reduction only in diabetic patients with established CV disease, not just those with CV risk factors. GLP-1 agonist's labeling is silent on discordant efficacy results in the US patient subgroup in the LEADER trial.
US advisory committee strongly endorses cardiovascular risk reduction claim for the GLP-1 agonist but some panelists say new indication should be limited to diabetics with established CV disease, not the broad primary prevention claim Novo Nordisk is seeking.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered