Report of Foreign Issuer (6-k)
03 May 2019 - 08:13PM
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
April 26, 2019
________________
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-________
Novo Nordisk files for EU regulatory
approval of oral semaglutide for the treatment of type 2 diabetes
Bagsværd, Denmark, 26 April 2019
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Novo Nordisk today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines
Agency (EMA) for oral semaglutide, a glucagon-like peptide-1 (GLP-1) analogue in a tablet taken once- daily, for the treatment
of adults with type 2 diabetes.
The submission is based on the results from 10 PIONEER clinical trials, which
included 9,543 adults with type 2 diabetes. In the PIONEER programme, people treated with oral semaglutide demonstrated greater
HbA
1c
reductions and weight loss in all completed head-to-head trials versus sitagliptin,
empagliflozin, liraglutide and dulaglutide, at the end of the trials. Across the PIONEER trials, oral semaglutide had a safe and
well- tolerated profile consistent with the GLP-1 receptor agonist (RA) class, with the most common adverse event being nausea.
“Achieving glycaemic control remains a challenge for people with
type 2 diabetes, and despite availability of several oral treatment options, a high proportion do not achieve target blood sugar
levels,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We are
excited about the regulatory filing of oral semaglutide in Europe, the first GLP-1 receptor agonist in a tablet, as we believe
oral semaglutide has the potential to further improve the treatment of adults living with type 2 diabetes.”
Oral semaglutide has now been submitted for regulatory approval in
the US, the EU and Canada.
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 (US)
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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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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 25 / 2019
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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: April 26, 2019
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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