Novo Nordisk submits application to regulatory authorities to include LEADER data in Victoza® label
(Thomson Reuters ONE) -
Bagsværd, Denmark, 25 October 2016 - Novo Nordisk today announced the submission
of a supplemental New Drug Application (sNDA) to the US Food and Drug
Administration (FDA) and a Type II Variation application to the European
Medicines Agency (EMA) for including data from the LEADER cardiovascular
outcomes trial in the product information of Victoza(®) (liraglutide).
In the LEADER trial, Victoza(®) statistically significantly reduced the risk of
cardiovascular death, non-fatal myocardial infarction (heart attack) and 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.
The safety profile of Victoza(®) in LEADER was generally consistent with
previous liraglutide clinical trials.
"Reducing the risk of cardiovascular death in people with type 2 diabetes
remains a significant unmet need and it is encouraging that we now have the
opportunity to help address this challenge," said Mads Krogsgaard Thomsen,
executive vice president and chief science officer of Novo Nordisk. "Victoza(®)
is the first GLP-1 receptor agonist to show cardiovascular risk reduction in
adults with type 2 diabetes at high cardiovascular risk and we look forward to
working with the regulatory authorities as they review the data from the LEADER
trial."
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 up to 1.8 mg) 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.
LEADER 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
myocardial infarction or non-fatal stroke.
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 85 countries, treating more than 1 million people with type 2 diabetes
globally. In Europe, Victoza(®) is indicated for the treatment of adults with
type 2 diabetes to achieve glycaemic control as monotherapy, when metformin is
considered inappropriate, and in combination with oral glucose-lowering
medicinal products and/or basal insulin when these, together with diet and
exercise, do not provide adequate glycaemic control. 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.
Further information
Media:
Anne Margrethe Hauge +45 4442 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
Melanie Raouzeos +45 3075 3479 mrz(at)novonordisk.com
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 72 / 2016
PR161025_Victoza_LEADER_filing_UK_CLEAN:
http://hugin.info/2013/R/2050994/767291.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: 25.10.2016 - 20:20 Uhr
Sprache: Deutsch
News-ID 502779
Anzahl Zeichen: 4485
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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