Novo’s Victoza CV Benefit Claim Could Be Narrowed With FDA Panel Vote
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.
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Novo Nordisk's ESC satellite symposium on heels of FDA approval of CV event prevention claim for Victoza highlights differences compared to Sanofi's competing Lyxumia, which failed an outcomes study.
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 Approvals Roundup: Cyltezo Biosimilar, Victoza CV Benefit, Gocovri In PD, Kedrab Rabies Biologic, Gout Combo Duzallo
FDA's clearances showcase the application of formulation technology to reduce problem side effects and improve convenience of available drugs.