FDA Advisory Committee Recommends Novo Nordisk’s Diabetes Combo Therapy
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The Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has recommend the approval of Novo Nordisk’s IDegLira for the treatment of adults with Type 2 diabetes. IDegLira is a once-daily, single injection fixed combination of insulin degludec (Tresiba), a once-daily new-generation basal insulin analogue, and liraglutide (Victoza), a once-daily GLP-1 analog, both products of Novo Nordisk.

The new drug application for IDegLira was submitted to the FDA in September 2015 under the FDA’s Prescription Drug User Fee Act V (PDUFA V) regulation. In Europe, IDegLira was approved in September 2014 and is marketed under the brand name Xultophy.

Source: Novo Nordisk

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