Report of Foreign Issuer (6-k)
January 10 2017 - 10:01AM
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
January 10, 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-________
Fiasp® (fast-acting insulin aspart) approved in
Europe
Bagsværd, Denmark, 10 January 2017
- Novo
Nordisk today announced that the
European Commission has granted marketing authorisation for Fiasp
®
for the treatment of diabetes in adults. The authorisation covers all 28 European Union member states.
Fiasp
®
is the brand name for fast-acting
insulin aspart. Fiasp
®
provides improved mealtime and overall glucose control
with a similar safety profile versus NovoRapid
®
.
"Fiasp
®
is a new-generation
mealtime insulin; it is an innovative faster formulation of insulin aspart that more closely mimics the physiological insulin response
around meals. The incremental benefits with Fiasp
®
are comparable to those
observed for the last generation of mealtime insulins when introduced more than a decade ago", said Mads Krogsgaard Thomsen,
executive vice president and chief science officer of Novo Nordisk.
Fiasp
®
will be available in vial,
Penfill
®
and FlexTouch
®
pen.
Novo Nordisk expects to launch Fiasp
®
in the first European countries in the first half of 2017.
About Fiasp
®
Fiasp
®
(fast-acting insulin aspart)
is an ultra-fast rapid-acting insulin now approved in Europe that improves control of postprandial glucose (PPG) excursions and
has been developed for the treatment of people with type 1 and type 2 diabetes, as well as for pump treatment.
Fiasp
®
is insulin aspart (NovoRapid
®
)
in a new formulation, in which two new excipients have been added to ensure earlier, greater and faster absorption, thereby providing
earlier insulin action. The review of Fiasp
®
was based on the onset programme,
a phase 3 clinical programme comprising of four trials encompassing more than 2,100 people with type 1 and type 2 diabetes.
Fiasp
®
also received marketing authorisation
from Health Canada on 6 January 2017, and has been filed for regulatory review in the US, Switzerland, Australia, Canada, Brazil,
South Africa and Argentina.
Page 2 of 2
Further information
Media:
|
|
|
Katrine Sperling
|
+45 4442 6718
|
krsp@novonordisk.com
|
Ken Inchausti (US)
|
+1 609 786 8316
|
kiau@novonordisk.com
|
|
|
|
Investors
:
|
|
|
Peter Hugreffe Ankersen
|
+45 3075 9085
|
phak@novonordisk.com
|
Melanie Raouzeos
|
+45 3075 3479
|
mrz@novonordisk.com
|
Hanna Ögren
|
+45 3079 8519
|
haoe@novonordisk.com
|
Anders Mikkelsen
|
+45 3079 4461
|
armk@novonordisk.com
|
Kasper Veje (US)
|
+1 609 235 8567
|
kpvj@novonordisk.com
|
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
|
|
|
Company announcement No 3 / 2017
|
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: January 10, 2017
|
NOVO NORDISK A/S
Lars Rebien Sørensen,
Chief Executive Officer
|
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