FDA advisory panel backs Sanofi's IGlarLixi for approval

26 May 2016

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday recommended the approval of the New Drug Application (for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.

The 15-member panel voted 12 to 2 (1 panelist did not vote due to travel) to approve French pharma major Sanofi’s (Euronext: SAN) fixed-ratio combination of the firm’s blockbuster diabetes treatment Lantus (basal insulin glargine) 100 Units/mL and GLP-1 receptor agonist lixisenatide, dubbed IGlarLixi.

The positive vote comes just a day after the same advisory panel gave its unanimous back to Novo Nordisk’s I DegLira, a single injection combination of insulin degludec (Tresiba) and liraglutide (Victoza).

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