FDA Questions Study Findings, Practicality of Novo Nordisk A/S's Diabetes Drug Ideglira

Bagsværd, Denmark, 20 May 2016 - Novo Nordisk announced today that the US Food and Drug Administration (FDA) has published the briefing documents ahead of the 24 May 2016 Advisory Committee meeting to discuss the New Drug Application (NDA) for IDegLira, the fixed combination product of insulin degludec (Tresiba^®) and liraglutide (Victoza^®).

The briefing documents from Novo Nordisk and the FDA, which will form the basis for the Advisory Committee's discussion, provide an overview of the non-clinical and clinical data for IDegLira for the treatment of type 2 diabetes.

The briefing materials can be accessed on the FDA webpage

FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing a new drug application. According to the FDA Amendment Act of 2007 (FDAAA), the FDA should refer new drugs to an advisory committee meeting, or alternatively justify why an advisory committee meeting was not requested.

IDegLira is a once-daily, single injection combination product consisting of insulin degludec (Tresiba^®), a once-daily new-generation basal insulin analogue, and liraglutide (Victoza^®), a once-daily GLP-1 analogue.  

IDegLira was submitted to the FDA in September 2015 under the US 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^®.

For further information

Company announcement No 41 / 2016