FDA Extends Review Of Novo Nordisk’s Diabetes Combo Therapy

The US Food and Drug Administration (FDA) has extended the review period for Novo Nordisk’s IDegLira, a fixed-ratio combination of insulin degludec and liraglutide 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.

Novo Nordisk submitted the NDA to the FDA in September 2015, and with the extension of the review, the action date is now expected in December 2016. A FDA advisory committee recommended approval of the drug in May 2016. In Europe, IDegLira was approved in September 2014 and is marketed under the brand name Xultophy.

IDegLira is a once-daily, single injection fixed combination product consisting of Novo Nordisk’s Tresiba (insulin degludec), a once-daily new-generation basal insulin analog, and Novo Nordiks’ Victoza (liraglutide), a once-daily glucagon-like peptide-1 receptor agonist analog.

Source: Novo Nordisk

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