NOVO NORDISK A/S 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:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm491062.htm
About advisory committee meetings
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.
About IDegLira
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
| Media: | ||
| Katrine Sperling | +45 3079 6718 | krsp@novonordisk.com |
| Ken Inchausti (US) | +1 609 786 8316 | kiau@novonordisk.com |
| Investors: | ||
| Peter Hugreffe Ankersen | +45 3075 9085 | phak@novonordisk.com |
| Melanie Raouzeos | +45 3075 3479 | mrz@novonordisk.com |
| Kasper Veje (US) | +1 609 235 8567 | kpvj@novonordisk.com |
Company announcement No 41 / 2016
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via Globenewswire
