f6k_032615.htm
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
 
March 26, 2015
________________
 
 
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.
 
Yes [  ]     
      No [X]
 
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-________
 
 
 
 
 
Novo Nordisk has decided to resubmit the New Drug Applications of Tresiba® and Ryzodeg® in the US
 
Bagsværd, Denmark, 26 March 2015  Novo Nordisk today announced that the company has decided to submit the prespecified interim analysis of DEVOTE as part of a Class II Resubmission of the New Drug Applications (NDAs) of Tresiba® and Ryzodeg® to the US Food and Drug Administration (FDA). The resubmission is expected to take place within the next month.
 
The cardiovascular outcomes trial for Tresiba® (insulin degludec), DEVOTE, was initiated in October 2013 and the required number of major adverse cardiovascular events (MACE) for the prespecified interim analysis were accumulated by the end of January 2015.
 
The result of an interim analysis carries a higher level of uncertainty than the final study results as this preliminary estimate is built on a substantially lower number of observations. Accordingly, the relative risk estimate that has been derived from the interim analysis is thus only an indication of the final trial results.
 
In addition to the data from the interim analysis of DEVOTE, the Class II Resubmission will comprise a safety update including data from all clinical trials with insulin degludec as well as an overview of postmarketing data.
 
Following the submission of the Class II Resubmission, the FDA is expected to communicate either its acceptance of the filing or issue an ‘Incomplete Response Letter’. This usually occurs within a month of resubmission.
 
To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data. Novo Nordisk management does not have access to the results of the interim analysis. The trial is expected to be completed in the second half of 2016.
 
 
 

 
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Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 41,500 employees in 75 countries, and markets its products in more than 180 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
 
 
For further information
 
Media:
Mette Kruse Danielsen
+45 3079 3883
mkd@novonordisk.com
Ken Inchausti (US)
+1 609 514 8316
kiau@novonordisk.com
     
Investors:
Kasper Roseeuw Poulsen
+45 3079 4303
krop@novonordisk.com
Melanie Raouzeos
+45 3075 3479
mrz@novonordisk.com
Daniel Bohsen
+45 3079 6376
dabo@novonordisk.com
Frank Daniel Mersebach (US)
+1 609 235 8567
fdni@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 23 / 2015
 
 
 

 
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: March 26, 2015
 
NOVO NORDISK A/S
 
Lars Rebien Sørensen,
Chief Executive Officer