An FDA advisory committee recommended approval of Sanofi’s combination candidate for Type 2 diabetes last week.
The committee voted 12-2 in favor of iGlarLixi, a fixed-ratio combination of insulin and a glucagon-like peptide-1 receptor agonist. The day before, the committee recommended approval of Novo Nordisk’s combination candidate for Type 2 diabetes.
The Endocrinologic and Metabolic Drugs Advisory Committee agreed that the candidate demonstrated superiority to comparator products in lowering A1c levels and featured a reasonable safety profile. However, members voiced concerns about the potential misuse of the proposed drug-delivery device.