FDA Advisory Committee unanimously recommends IDegLira (insulin degludec + liraglutide) for treatment of type 2 diabetes. -Novo Nordisk

Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA voted 16-0, recommending the approval of IDegLira (insulin degludec + liraglutide) for the treatment of adults with type 2 diabetes. 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.

Based on the data contained in the New Drug Application (NDA) 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. The recommendation for approval was based on data from clinical trials of IDegLira, including the DUAL phase III clinical trial programme, which involved more than 3,000 adults with type 2 diabetes. In addition to the DUAL clinical trial programme, both insulin degludec and liraglutide have been studied extensively in separate clinical trial programmes and the products are commercially available across the globe.

Comment: The combination was EU approved in September 2014 as Xultophy.