Report of Foreign Issuer (6-k)
June 16 2017 - 9:32AM
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
June 16, 2017
________________
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-________
FDA
posts briefing materials prior to Advisory Committee meeting for Victoza® label update
Bagsværd, Denmark, 16 June 2017
– Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published the briefing documents ahead
of the Advisory Committee meeting to discuss the supplemental New Drug Application (sNDA) for approval of Victoza
®
(liraglutide) injection to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction,
or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk, given as an adjunct to standard treatment
of cardiovascular risk factors.
The meeting takes place on 20 June 2017. The
briefing documents from Novo Nordisk and the FDA form the basis for the Advisory Committee’s discussion, and provide an overview
of the clinical data from the cardiovascular outcomes trial LEADER.
The briefing materials can be accessed on the FDA webpage: https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Endocrino
logicandMetabolicDrugsAdvisoryCommittee/ucm560480.htm
About advisory committees
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 data concerning the safety and
effectiveness of marketed or new drug applications.
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
Page 2 of 2
cardiovascular outcome comprising cardiovascular
death, non-fatal myocardial infarction or non-fatal stroke.
About Victoza
®
Victoza
®
(liraglutide) injection 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 90 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 42,000 people in 77 countries and markets its products in more than 165 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:
|
Katrine Sperling
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+45 4442 6718
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krsp@novonordisk.com
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Ken Inchausti (US)
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+1 609 786 8316
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kiau@novonordisk.com
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|
|
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Investors
:
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Peter Hugreffe Ankersen
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+45 3075 9085
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phak@novonordisk.com
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Hanna Ögren
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+45 3079 8519
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haoe@novonordisk.com
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Anders Mikkelsen
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+45 3079 4461
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armk@novonordisk.com
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Kasper Veje (US)
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+1 609 235 8567
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kpvj@novonordisk.com
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Novo Nordisk A/S
Investor Relations
|
Novo Allé
2880 Bagsværd
Denmark
|
Telephone:
+45 4444 8888
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Internet:
www.novonordisk.com
CVR no: 24 25 67 90
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Company announcement No 45 / 2017
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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: June 16, 2017
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
|
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