FDA extends regulatory review period for IDegLira by three months

5 September 2016

Danish diabetes care giant Novo Nordisk (NOV: N) announced on Friday that the US Food and Drug Administration has extended the regulatory review period for IDegLira, the fixed-ratio combination of insulin degludec (Tresiba) and liraglutide (Victoza) in adults with type 2 diabetes.

The FDA informed Novo Nordisk that a three-month extension was required in order to complete its review of the New Drug Application (NDA) for IDegLira.

In May this year, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes.

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