Novo Nordisk A/S: Victoza® has been approved in the EU as the only GLP-1 with a label to include prevention of cardiovascular events
(Thomson Reuters ONE) -
Bagsværd, Denmark, 27 July 2017 - The European Commission has approved an update
to the Victoza(®) (liraglutide) EU label that expands the indication to reflect
both improving blood sugar and cardiovascular (CV) events as integral parts of
type 2 diabetes treatment. Victoza(®) is the only GLP-1 that is proven to
prevent CV events in people with type 2 diabetes and high CV risk.
The updated label includes results from the LEADER trial, which demonstrated
that Victoza(®) statistically significantly reduced the risk of cardiovascular
death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by
13% versus placebo, when added to standard of care. The overall risk reduction
was derived from a statistically significant 22% reduction in cardiovascular
death with Victoza(®) treatment versus placebo and non-significant reductions in
non-fatal myocardial infarction and non-fatal stroke.
"Cardiovascular disease is the number one cause of death for people with type 2
diabetes and requires treatment strategies that can tackle both blood glucose
and cardiovascular risk to help improve outcomes," said Mads Krogsgaard Thomsen,
executive vice president and chief science officer of Novo Nordisk. "The
European Commission's approval of the expanded Victoza(®) label enables
physicians to provide their patients with the only GLP-1 proven to prevent
cardiovascular events in people with type 2 diabetes and high cardiovascular
risk."
About Victoza(®)
Victoza(®) (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue
with an amino acid sequence 97% similar to endogenous human GLP-1. Victoza(®)
was approved in the EU in 2009 and is commercially available in more than 95
countries, treating more than 1 million people with type 2 diabetes globally. In
Europe, Victoza(®) is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes together with diet and exercise, as monotherapy when
metformin is considered inappropriate due to intolerance or contraindications
and in addition to other medicinal products for the treatment of type 2
diabetes. In the US, Victoza(®) was approved in 2010 as an adjunct to diet and
exercise to improve blood glucose control in adults with type 2 diabetes.
About the LEADER trial
LEADER was a multicentre, international, randomised, double-blind, placebo-
controlled trial investigating the long-term (3.5-5 years) effects of Victoza(®)
(liraglutide) compared to placebo, both in addition to standard of care, in
people with type 2 diabetes at high risk of major cardiovascular events.
Standard of care was comprised of lifestyle modifications, glucose-lowering
treatments and cardiovascular medications.
The landmark LEADER trial was initiated in September 2010 and randomised 9,340
people with type 2 diabetes from 32 countries. The primary endpoint was the
first occurrence of a composite cardiovascular outcome comprising cardiovascular
death, non-fatal heart attack or non-fatal stroke.
Further information
Media:
Anne Margrethe Hauge +45 3079 3450 amhg(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
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Anders Mikkelsen +45 3079 4461 armk(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 57 / 2017
PR170727_Victoza_EU_approval_label_update_UK:
http://hugin.info/2013/R/2123790/810200.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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
Unternehmensinformation / Kurzprofil:
Datum: 27.07.2017 - 18:33 Uhr
Sprache: Deutsch
News-ID 554286
Anzahl Zeichen: 4406
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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