Report of Foreign Issuer (6-k)
29 April 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]
|
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-________
Novo
Nordisk receives positive opinion from the European regulatory authorities for Esperoct
®
(turoctocog alfa pegol,
N8-GP) for the treatment of haemophilia A
Bagsværd, Denmark,
26 April 2019
– Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP), under the
European Medicines Agency (EMA), adopted a positive opinion for the use of Esperoct
®
(turoctocog alfa pegol, N8-GP) recommending marketing authorisation for the treatment of adolescents and adults with haemophilia
A.
The CHMP recommends Esperoct
®
,
the brand name for turoctocog alfa pegol, N8-GP, to be indicated for prophylaxis and on-demand treatment of bleeding as well as
for surgical procedures in adolescents (≥12 years of age) and adults with haemophilia A (congenital factor VIII deficiency).
The recommendation is based on the results from the largest pre- registration clinical programme conducted in haemophilia A, with
inclusion of 270 previously treated people (PTPs) with severe haemophilia A and more than 5 years of clinical exposure.
“We are happy to receive
the positive opinion for Esperoct
®
in the EU, and we consider it an important
expansion of the treatment options Novo Nordisk can offer people with haemophilia A,” said Mads Krogsgaard Thomsen, executive
vice president and chief science officer of Novo Nordisk. “We are confident that Esperoct
®
can provide a less burdensome and simple dosing regimen for prophylaxis and treatment of bleeding episodes, resulting
in improved quality of life for people with haemophilia A.”
About Esperoct
®
Esperoct
®
(turoctocog alfa pegol, N8-GP) is an extended half-life factor VIII molecule for replacement therapy in people with
haemophilia A, which provides a 1.6-fold half-life prolongation in adults/adolescents compared to standard half-life factor VIII
products.
Esperoct
®
was shown to provide effective routine prophylaxis in people with severe haemophilia A through a simple, fixed dosing
regimen of one injection every 4 days in adults and adolescents. Esperoct
®
provided
effective prophylaxis and maintained a low median ABR of 1.18 when dosed at 50 IU/kg every 4 days in adults and adolescents.
Page 2 of 2
Furthermore, Esperoct
®
was found to be efficacious in treatment and control of bleeding episodes and perioperative management. Across the
clinical trials and age groups, Esperoct
®
was well tolerated and no safety
concerns were identified. The overall safety profile of Esperoct
®
is similar
to what has been reported for other long-action FVIII products.
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 43,200 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 and YouTube.
Further information
Media:
|
|
|
Mette Kruse Danielsen
|
+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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|
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Investors
:
|
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Peter Hugreffe Ankersen
|
+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
|
Ann Søndermølle Rendbæk
|
+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
|
Novo Allé
2880 Bagsværd
Denmark
|
Telephone:
+45 4444 8888
|
Internet:
www.novonordisk.com
CVR no:
24 25 67 90
|
|
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Company announcement No 26 / 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
|
NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
|
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