FDA Advisory Committee Recommends Novo Nordisk’s Diabetes Combo Therapy
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