Report of Foreign Issuer (6-k)
June 14 2017 - 9:02AM
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 14, 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-________
Novo
Nordisk submits application in the EU for including data from the DEVOTE trial in the Tresiba® label
Bagsværd, Denmark, 14 June 2017
– Novo Nordisk today announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for
including data in the label for Tresiba
®
(insulin degludec) from the DEVOTE trial, a long-term,
randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba
®
compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.
In the DEVOTE trial, the primary endpoint was
achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba
®
compared to insulin glargine U100. The primary endpoint was defined as the MACE composite outcome of the first occurrence of cardiovascular
death, non-fatal myocardial infarction or non-fatal stroke and showed a hazard ratio of 0.91 in favour of Tresiba
®
relative to insulin glargine U100, with no statistically significant difference between the two treatments.
From a mean HbA
1c
baseline of 8.4%, the trial showed a similar reduction with Tresiba
®
compared to insulin
glargine U100 with an end-of-trial treatment difference of 0.01 percentage points between the two treatment arms, thus fulfilling
the requirements for objectively comparing hypoglycaemia rates between the two treatments.
In the trial, Tresiba
®
demonstrated superiority on the secondary confirmatory endpoint of severe hypoglycaemia: 27% fewer patients in the Tresiba
®
treated group experienced an episode of severe hypoglycaemia, resulting in a 40% overall rate reduction of total episodes of adjudicated
severe hypoglycaemia. Furthermore, patients in the Tresiba
®
treated group experienced
a 53% relative reduction in the rate of nocturnal severe hypoglycaemia. These differences were all statistically significant.
Tresiba
®
appeared to have a safe and well-tolerated profile consistent with previous clinical studies conducted with Tresiba
®
.
Page 2 of 2
“The risk of severe hypoglycaemia is a
major cause for people with type 2 diabetes not reaching their treatment targets,” said Mads Krogsgaard Thomsen, executive
vice president and chief science officer of Novo Nordisk. “However, with the DEVOTE data, we have demonstrated that the strong
clinical profile of Tresiba
®
leads to a significant reduction in severe hypoglycaemia
in people with type 2 diabetes.”
About DEVOTE
DEVOTE is a long-term, multi-centre, multi-national,
randomised, double-blinded, parallel group and event-driven trial conducted to confirm the cardiovascular safety of Tresiba
®
(insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people with type 2 diabetes at high risk of cardiovascular
disease were randomised to treatment with either Tresiba
®
or insulin glargine U100 in
vial in addition to standard of care.
About Tresiba
®
Tresiba
®
(insulin degludec) is a once-daily basal insulin that provides duration of action of at least 42 hours. Tresiba
®
is taken once daily, at any time of day. Patients who miss or are delayed in taking their dose of Tresiba
®
can take their dose as soon as they remember, but ensuring there are at least eight hours between doses. Tresiba
®
was approved by the European Commission in January 2013 and has since been approved in more than 80 countries globally.
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
|
+45 4442 6718
|
krsp@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
|
Hanna Ögren
|
+45 3079 8519
|
haoe@novonordisk.com
|
Anders Mikkelsen
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+45 3079 4461
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armk@novonordisk.com
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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
|
|
|
Company announcement No 44 / 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 14, 2017
|
NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
|
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