Report of Foreign Issuer (6-k)
January 31 2020 - 10:30AM
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 31, 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]
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Form 40-F [ ]
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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-________
Rybelsus® (oral
semaglutide) recommended for approval for the treatment of adults with type 2 diabetes by the European regulatory authorities
Bagsværd, Denmark, 31 January 2020
- Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines
Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Rybelsus®
(oral semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic
control as an adjunct to diet and exercise.
The CHMP recommends Rybelsus®
to be indicated as monotherapy when metformin is considered inappropriate, as well as in combination with other medicinal
products for the treatment of type 2 diabetes. The label also refers to clinical trial results with respect to combination with
other diabetes medications, effects on glycaemic control, cardiovascular events and the populations studied.
“We are very excited about the positive
opinion for Rybelsus®, as it is the first and only GLP-1 in a tablet, and
we believe it has the potential to set a new standard for the treatment of type 2 diabetes in the EU,” said Mads Krogsgaard
Thomsen, executive vice president and chief science officer. “A high proportion of people with type 2 diabetes does not
achieve target blood sugar levels, which underpins the need for new and more efficacious solutions to better manage their disease.”
Novo Nordisk expects to receive final marketing
authorisation from the European Commission in the beginning of second quarter of 2020.
About Rybelsus®
Rybelsus®
(oral semaglutide) is an analogue of the naturally occurring hormone GLP-1, and it is the world’s first and
only GLP-1 in a tablet. Rybelsus® is approved in the US and it is indicated
as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. It is administered once daily
and is approved for use in two therapeutic dosages, 7 mg and 14 mg in the US.
Page 2 of 2
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.
Further information
Media:
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Mette Kruse Danielsen
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+45 4442 3883
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mkd@novonordisk.com
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Ken Inchausti (USA)
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+1 609 240 9429
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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 (USA)
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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 5 / 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 31, 2020
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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