Report of Foreign Issuer (6-k)
April 06 2020 - 6:06AM
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 4, 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) approved for the treatment of adults with type 2 diabetes in the EU
Bagsværd, Denmark, 4 April 2020 - Novo Nordisk today announced
that the European Commission (EC) has granted 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 marketing authorisation applies to all 27 European Union member states and the United Kingdom.
Rybelsus® is the first and only
oral glucagon-like-peptide-1 (GLP-1) receptor agonist. The approval is based on the results from 10 PIONEER clinical trials, in
which Rybelsus® after 52 weeks demonstrated statistically significant reductions in HbA1c
vs sitagliptin, empagliflozin and liraglutide and with up to 4.3 kg weight reduction. Across the PIONEER programme, Rybelsus®
demonstrated a safe and well-tolerated profile, with the most common adverse event being mild to moderate nausea which diminished
over time.
“We are very excited about the approval of Rybelsus®
as we can now offer people in Europe living with type 2 diabetes the first and only GLP-1 in a tablet,” said Mads
Krogsgaard Thomsen, executive vice president and chief science officer. “Based on its strong clinical profile, we believe
Rybelsus® has the potential to set a new standard for the treatment of type 2 diabetes,
as millions of people are currently not achieving target blood sugar levels on available oral antidiabetic medications.”
The launch of Rybelsus®
is expected to take place in the first EU countries in the second half of 2020.
About Rybelsus®
Rybelsus® (oral
semaglutide) is an analogue of the naturally occurring hormone GLP-1. Rybelsus® is approved
in the US, Switzerland and EU as an adjunct to diet and exercise to improve glycemic 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.
Rybelsus® is
currently under review by several regulatory agencies, including the Japanese Pharmaceuticals and Medical Devices Agency.
Page 2 of 2
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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+1 609 240 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 21 / 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: April 6, 2020
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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