IDegLira gets unanimous FDA advisory panel vote in favor of approval

25 May 2016

Despite slightly negative briefing documents ahead of the US Food and Drug Administration advisory panel meeting (The Pharma Letter May 24), the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes.

Danish diabetes care giant Novo Nordisk’s (NOV: N) IDegLira is a once-daily, single injection fixed combination of insulin degludec (Tresiba) and liraglutide (Victoza) for the treatment of adults with type 2 diabetes. Novo Nordisk’s shares were up 2.5% at 373.50 Danish kronor in early trading today.

Based on the data contained in the New Drug Application for IDegLira, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with type 2 diabetes.

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