UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549  

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FORM 6-K

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REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934

December 31, 2012

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        NOVO NORDISK A/S        
(Exact name of Registrant as specified in its charter)

Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)

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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or 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-_____________________

 

 

Ryzodeg^® (insulin degludec/insulin aspart) approved in Japan

 

Bagsværd, Denmark, 25 December 2012 – Novo Nordisk today announced that the Japanese Ministry of Health, Labour and Welfare has approved Ryzodeg^® (insulin degludec/insulin aspart) for the treatment of diabetes.

 

Ryzodeg^® is a soluble formulation of Tresiba^® (insulin degludec), a once-daily new-generation basal insulin analogue with an ultra-long duration of action, and NovoRapid^® (insulin aspart which in the US is marketed under the brand name NovoLog^®). Ryzodeg^® can be administered once or twice daily with the main meal(s). In global ‘treat-to-target’ studies supporting the new drug application, where Ryzodeg^® was compared to NovoMix^®, Ryzodeg^® demonstrated a significantly lower risk of nocturnal hypoglycaemia while successfully achieving equivalent reductions in HbA_1c.

 

In Japan, Ryzodeg^® will be available in FlexTouch^®, Novo Nordisk’s latest prefilled insulin pen, which has an easy auto-injector mechanism, and in Penfill^® for Novo Nordisk’s durable insulin pens.

 

“We are excited about the approval of Ryzodeg^®”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The unique properties of Ryzodeg^® provide the potential to improve treatment for people with diabetes in Japan”.

 

About Tresiba^® and Ryzodeg^®

Tresiba^® is the global brand name for insulin degludec, a once-daily new-generation basal insulin analogue with an ultra-long duration of action, discovered and developed by Novo Nordisk. Tresiba^® has a distinct, slow absorption which provides a flat and stable action profile. Tresiba^® has been studied in a large-scale clinical trial programme, BEGIN™, examining its impact on glucose control, hypoglycaemia and the possibility to flexibly adjust Tresiba^® dosing time to suit patient needs.

 

Ryzodeg^®, the global brand name for insulin degludec/insulin aspart contains Tresiba^®, a once-daily new-generation basal insulin analogue in a formulation with a bolus boost of NovoRapid^®. Ryzodeg^® is the first and only soluble insulin combination of Tresiba^® and

 

 

 

 

 

the most prescribed rapid-acting insulin, NovoRapid^® (NovoLog^® in the US), providing both fasting and post-prandial glucose control.

 

Tresiba^® and Ryzodeg^® were submitted for regulatory approval to the Japanese Ministry of Health, Labour and Welfare in December 2011 and March 2012, respectively. Tresiba^® was approved in Japan in September 2012. In October 2012, Tresiba^® and Ryzodeg^® received positive CHMP opinions in the EU. In November, the products received a positive vote for approval from an FDA Advisory Committee. In addition, applications have been submitted for regulatory approval in Canada, Switzerland and a range of other countries.

 

Novo Nordisk is a global healthcare company with 89 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 33,900 employees in 75 countries, and markets its products in more than 190 countries. Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com.  

 

 

 

 

 

 

 

 

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.