NVO Novo Nordisk

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

 

June 14, 2017

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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

 

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 submits application in the EU for including data from the DEVOTE trial in the Tresiba® label

 

Bagsværd, Denmark, 14 June 2017 – Novo Nordisk today announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for including data in the label for Tresiba ® (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba ® compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.

 

In the DEVOTE trial, the primary endpoint was achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba ® compared to insulin glargine U100. The primary endpoint was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke and showed a hazard ratio of 0.91 in favour of Tresiba ® relative to insulin glargine U100, with no statistically significant difference between the two treatments.

 

From a mean HbA _1c baseline of 8.4%, the trial showed a similar reduction with Tresiba ® compared to insulin glargine U100 with an end-of-trial treatment difference of 0.01 percentage points between the two treatment arms, thus fulfilling the requirements for objectively comparing hypoglycaemia rates between the two treatments.

 

In the trial, Tresiba ® demonstrated superiority on the secondary confirmatory endpoint of severe hypoglycaemia: 27% fewer patients in the Tresiba ® treated group experienced an episode of severe hypoglycaemia, resulting in a 40% overall rate reduction of total episodes of adjudicated severe hypoglycaemia. Furthermore, patients in the Tresiba ® treated group experienced a 53% relative reduction in the rate of nocturnal severe hypoglycaemia. These differences were all statistically significant.

 

Tresiba ® appeared to have a safe and well-tolerated profile consistent with previous clinical studies conducted with Tresiba ® .

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“The risk of severe hypoglycaemia is a major cause for people with type 2 diabetes not reaching their treatment targets,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “However, with the DEVOTE data, we have demonstrated that the strong clinical profile of Tresiba ® leads to a significant reduction in severe hypoglycaemia in people with type 2 diabetes.”

 

About DEVOTE

DEVOTE is a long-term, multi-centre, multi-national, randomised, double-blinded, parallel group and event-driven trial conducted to confirm the cardiovascular safety of Tresiba ® (insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people with type 2 diabetes at high risk of cardiovascular disease were randomised to treatment with either Tresiba ® or insulin glargine U100 in vial in addition to standard of care.

 

About Tresiba ®

Tresiba ® (insulin degludec) is a once-daily basal insulin that provides duration of action of at least 42 hours. Tresiba ® is taken once daily, at any time of day. Patients who miss or are delayed in taking their dose of Tresiba ® can take their dose as soon as they remember, but ensuring there are at least eight hours between doses. Tresiba ® was approved by the European Commission in January 2013 and has since been approved in more than 80 countries globally.

 

 

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 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
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 44 / 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: June 14, 2017

NOVO NORDISK A/S   Lars Fruergaard Jørgensen Chief Executive Officer