Report of Foreign Issuer (6-k)
26 October 2016 - 9:05PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________
FORM 6-K
________________
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
October 25, 2016
________________
NOVO NORDISK A/S
(Exact name
of Registrant as specified in its charter)
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
________________
Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F
Form 20-F [X]
|
Form 40-F [ ]
|
Indicate by check mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
If “Yes” is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g-32(b):82-________
Novo Nordisk submits application to regulatory authorities
to include LEADER data in Victoza® label
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.
Page 2 of 2
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.
Novo Nordisk is a global healthcare
company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities
that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered
in Denmark, Novo Nordisk employs approximately 42,300 people in 75 countries and markets its products in more than 180 countries.
Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For
more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information
Media:
|
Anne Margrethe Hauge
|
+45 4442 3450
|
amhg@novonordisk.com
|
Ken Inchausti (US)
|
+1 609 786 8316
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kiau@novonordisk.com
|
|
|
|
Investors
:
|
Peter Hugreffe Ankersen
|
+45 3075 9085
|
phak@novonordisk.com
|
Melanie Raouzeos
|
+45 3075 3479
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mrz@novonordisk.com
|
Hanna Ögren
|
+45 3079 8519
|
haoe@novonordisk.com
|
Kasper Veje (US)
|
+1 609 235 8567
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kpvj@novonordisk.com
|
Novo Nordisk A/S
Investor Relations
|
Novo Allé
2880 Bagsværd
Denmark
|
Telephone:
+45 4444 8888
|
Internet:
www.novonordisk.com
CVR no:
24 25 67 90
|
|
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Company announcement No 72 / 2016
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: October 25, 2016
|
NOVO NORDISK A/S
Lars Rebien Sørensen,
Chief Executive Officer
|
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