Report of Foreign Issuer (6-k)
18 January 2020 - 8:21AM
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
January 16, 2020
________________
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-________
Ozempic®
approved in the US for CV risk reduction in people with type 2 diabetes
and established CVD
Rybelsus®
label updated with additional information from the PIONEER 6 CV outcomes trial
Bagsværd,
Denmark, 16 January 2020 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved
a label expansion based on a supplemental New Drug Application (sNDA) for Ozempic® (once-weekly
semaglutide) for the indication of reducing the risk of major adverse cardiovascular events (MACE) including cardiovascular death,
non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes and established cardiovascular disease (CVD).
The approval is based
on the SUSTAIN 6 cardiovascular outcomes trial (CVOT), which demonstrated that Ozempic® statistically
significantly reduced the risk of CV death, non- fatal heart attack or non-fatal stroke by 26% versus placebo, when added to standard
of care in people with type 2 diabetes with increased CV risk.
The FDA also updated
the Rybelsus® label to include additional information from the PIONEER 6 CVOT demonstrating
CV safety. Rybelsus® demonstrated CV safety by meeting the primary endpoint of non-inferiority
for the composite MACE endpoint. The proportion of patients who experienced at least one MACE was 3.8% with Rybelsus®
and 4.8% with placebo.
“We strongly
believe in the benefits of semaglutide and this approval marks an important milestone. Ozempic®
now offers people in the US with type 2 diabetes and established cardiovascular disease an effective treatment option to
both lower their blood glucose and reduce their cardiovascular risk,” said Mads Krogsgaard Thomsen, executive vice president
and chief science officer of Novo Nordisk. “We also appreciate that the results from the PIONEER 6 study are reflected in
the label for Rybelsus® and to further evaluate the cardiovascular risk reduction profile
we are currently conducting the cardiovascular outcomes trial, SOUL.”
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About
Ozempic®
Ozempic®
(once-weekly semaglutide) is an analogue of the naturally occurring hormone glucagon-like peptide-1 (GLP-1). It is administered
in a once-weekly injection of 0.5 mg or 1 mg and indicated as an adjunct to diet and exercise to improve glycaemic control in
adults with type 2 diabetes as well as to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
and established cardiovascular disease. Ozempic® was first approved by the US FDA in
2017 and is now launched in 25 countries.
About
Rybelsus®
Rybelsus®
(oral semaglutide) is an analogue of the naturally occurring hormone GLP-1, and it is indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with type 2 diabetes. Rybelsus® is the
world’s first and only GLP-1 in a tablet. It is administered once daily and is approved for use in two therapeutic dosages,
7 mg and 14 mg.
Rybelsus®
was approved by the US FDA in September 2019 and is currently under review by several regulatory agencies, including the
European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
About
SUSTAIN 6 and PIONEER 6
SUSTAIN 6 was an
event and time-driven CVOT for Ozempic®. It was a randomised, double-blinded, placebo-controlled
trial evaluating the CV safety of Ozempic® versus placebo when added to standard of care
in 3,297 adults with type 2 diabetes with established CVD or high risk of CV events.
PIONEER 6 was a purely
event-driven, pre-approval CVOT for oral semaglutide. It was a randomised, double-blinded, placebo-controlled trial evaluating
the CV safety of Rybelsus® versus placebo when added to standard of care in 3,183 adults
with type 2 diabetes with established CVD or high risk of CV events.
About
the SOUL trial
Novo Nordisk is conducting
SOUL, a CVOT for Rybelsus® in 9,642 people with type 2 diabetes and established cardiovascular
disease, investigating the effects of oral semaglutide on the incidence of MACE, compared to placebo, both on top of standard
of care.
Novo Nordisk is
a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us
experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious
chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 42,200 people in 80 countries and markets its products
in more than 170 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.
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3 of 3
Further information
Media:
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Mette Kruse Danielsen
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+45 3079 3883
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mkd@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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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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Valdemar Borum Svarrer
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+45 3079 0301
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jvls@novonordisk.com
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Ann Søndermølle Rendbæk
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+45 3075 2253
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arnd@novonordisk.com
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Mark Joseph Root
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+45 3079 4211
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mjhr@novonordisk.com
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Kristoffer Due Berg (US)
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+1 609 235 2989
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krdb@novonordisk.com
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Novo Nordisk
A/S
Investor Relations
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Novo Allé
2880 Bagsværd
Denmark
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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 2 / 2020
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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: January 16, 2020
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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