Report of Foreign Issuer (6-k)
June 06 2017 - 12:49PM
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
June 6, 2017
________________
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-________
Refixia®
(nonacog beta pegol; N9-GP) approved in the EU
Bagsværd, Denmark, 6 June 2017
– Novo Nordisk today
announced that the European Commission has granted marketing authorisation for Refixia
®
for
the treatment of adolescents and adults with haemophilia B. The authorisation covers all 28 European Union member states.
Refixia
®
is the brand name
for nonacog beta pegol; N9-GP. Refixia
®
is indicated for prophylaxis, on-demand treatment
of bleeding and surgical procedures in adolescent (
>
12 years of age) and adult patients with haemophilia B (congenital
factor IX deficiency). The efficacy and safety evaluation was based on 115 patients across the five paradigm clinical trials, and
the marketing authorisation follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under
the European Medicines Agency (EMA), provided 24 March 2017.
“We are excited about the approval of Refixia
®
in the EU, and we consider it an important expansion of the treatment options for patients with haemophilia B,” said
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The strong clinical profile
of Refixia
®
provides haemophilia B patients with better protection against bleeds, even
into damaged joints, and an overall improved quality of life.”
Novo Nordisk expects to launch Refixia
®
in the first European countries in the fourth quarter of 2017.
About Refixia
®
Refixia
®
(nonacog
beta pegol; N9-GP) is an extended half-life factor IX molecule for replacement therapy in patients with haemophilia B.
Glycopegylation, the prolongation technology used for the half-life extension, is a novel approach in haemophilia B.
Pegylated products have been approved in haemophilia A and other therapeutic areas. The review of Refixia
®
was
based on the paradigm programme, a phase 3 clinical programme enrolling children and adults with severe or moderately severe
haemophilia B. In the programme, 115 previously treated patients had a total of more than 8,800 exposure days for up to 2.7
years of treatment with Refixia
®
. On 31 May 2017, Novo Nordisk received the US FDA
approval of nonacog beta pegol; N9-GP indicated for on- demand treatment and control of bleeding episodes and the
perioperative management of bleeding around the time of surgery in adults and children with haemophilia B.
Page 2 of 2
Novo Nordisk is
a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us
experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders
and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products
in more than 165 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:
|
|
|
Katrine Sperling
|
+45 3079 6718
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krsp@novonordisk.com
|
Ken Inchausti (US)
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+1 609 786 8316
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kiau@novonordisk.com
|
|
|
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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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Hanna Ögren
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+45 3079 8519
|
haoe@novonordisk.com
|
Anders Mikkelsen
|
+45 3079 4461
|
armk@novonordisk.com
|
Kasper Veje (US)
|
+1 609 235 8567
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kpvj@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 42 / 2017
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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: June 6, 2017
|
NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
|
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