Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
December 29 2020 - 8:17AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
December 29, 2020
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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 once-weekly semaglutide
2.0 mg for the treatment of type 2 diabetes
Bagsværd,
Denmark, 29 December 2020 – Novo Nordisk today announced the submission of a label extension application to the
European Medicines Agency (EMA) for the existing marketing authorisation for Ozempic®,
a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. Ozempic®
is currently approved in the EU in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults.
The submission is based on the results from the
SUSTAIN FORTE trial, which included 961 people with type 2 diabetes in need of treatment intensification. In the trial, people
treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in HbA1c at week 40 compared
to semaglutide 1.0 mg. In the trial, both doses of semaglutide appeared safe and well-tolerated. The most common adverse events
were gastrointestinal, the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor
agonist class. Compared to semaglutide 1.0 mg, the gastrointestinal adverse events were similar for semaglutide 2.0 mg.
“Following the announcement of the headline results
in November, we have expeditiously prepared the submission file. The submission in the EU represents an important milestone for
people living with type 2 diabetes who have poor glycaemic control and need treatment intensification” said Mads Krogsgaard
Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "With the 2.0 mg dose, more people with type
2 diabetes will be able to achieve treatment target”.
About the SUSTAIN clinical programme
The SUSTAIN clinical development programme for
once-weekly subcutaneous semaglutide injection currently comprises 11 phase 3 global clinical trials, including a cardiovascular
outcomes trial, involving more than 11,000 adults with type 2 diabetes.
For more information about the SUSTAIN Forte trial,
please read the headline results here (https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=34777)
Page 2 of 2
About Novo Nordisk
Novo
Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to
defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering
scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs
about 44,000 people in 80 countries and markets its products in around 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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Martin Havtorn Petersen
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+45 3075 5246
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mhpz@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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Daniel Muusmann Bohsen
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+45 3075 2175
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dabo@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 80 / 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: December 29, 2020
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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