FDA posts briefing materials prior to Advisory Committee meeting for IDegLira, a fixed combination product of insulin degludec and liraglutide
(Thomson Reuters ONE) -
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/Endocrino
logicandMetabolicDrugsAdvisoryCommittee/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(at)novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau(at)novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak(at)novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 41 / 2016
Company announcement No 41 / 2016:
http://hugin.info/2013/R/2014217/746688.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novo Nordisk A/S via GlobeNewswire
[HUG#2014217]
Unternehmensinformation / Kurzprofil:
Datum: 20.05.2016 - 14:36 Uhr
Sprache: Deutsch
News-ID 472612
Anzahl Zeichen: 3118
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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