Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
2024年3月5日 - 10:29PM
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
March 5, 2024
________________
NOVO NORDISK A/S
(Exact name
of Registrant as specified in its charter)
Novo Allé 1
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
Semaglutide 1.0 mg demonstrates 24% reduction in the risk of kidney disease-related events in people with type 2 diabetes and chronic kidney disease in the FLOW trial
Bagsværd, Denmark, 5 March 2024 – Novo Nordisk today announced
the headline results from the kidney outcomes trial FLOW. The announcement today follows the decision to stop the trial early due to
efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind
trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for prevention of progression of kidney impairment
and risk of kidney and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD). The trial enrolled 3,533
people with type 2 diabetes and CKD.
The trial achieved its primary endpoint by demonstrating a statistically significant and
superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24% for people treated with
semaglutide 1.0 mg compared to placebo1. The combined primary endpoint included five components measuring the progression
of CKD and the risk of kidney and cardiovascular mortality. Both CKD and cardiovascular components of the primary endpoint
contributed to the risk reduction. Further, superiority of semaglutide 1 mg vs placebo was confirmed for the confirmatory secondary
endpoints.
In the trial, semaglutide 1.0 mg appeared to have a safe and well-tolerated
profile in line with previous semaglutide 1.0 mg trials.
"We are very excited about the results from FLOW showing that semaglutide
1.0 mg reduces the risk of kidney disease progression,” said Martin Holst Lange, executive vice president for Development at Novo
Nordisk. “Approximately 40% of people with type 2 diabetes have chronic kidney disease, so the positive results from FLOW demonstrate
the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease.”
Page 2 of 3
Novo Nordisk expects to file for regulatory
approvals of a label expansion for Ozempic® in the US and EU in 2024. The detailed results from
FLOW will be presented at a scientific conference in 2024.
About FLOW
FLOW was a randomised, double-blind, parallel-group, placebo-controlled, superiority trial comparing
injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care on kidney outcomes for prevention of progression of kidney
impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and CKD (defined as eGFR2
≥50 and ≤75mL/min/1.73 m2 and UACR >300 and <5000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 and UACR >100
and <5000 mg/g). 3,533 people were enrolled in the trial conducted in 28 countries at around 400 investigator sites. The FLOW trial
was initiated in 2019.
The key objective of the FLOW trial is to demonstrate delay in progression of CKD and to lower
the risk of kidney and cardiovascular mortality through the composite primary endpoint consisting of the following five components: onset
of persistent ≥ 50% reduction in eGFR according to the CKD-EPI3 equation compared
with baseline, onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy (dialysis
or kidney transplantation), death from kidney disease or death from cardiovascular disease. Confirmatory secondary endpoints include
annual rate of change in eGFR1 (CKD-EPI), MACE (non-fatal myocardial infarction, non-fatal
stroke, cardiovascular death) and all-cause death.
About Ozempic®
Once-weekly subcutaneous semaglutide is approved in 0.5 mg, 1.0 mg and 2.0 mg
doses under the brand name Ozempic® and indicated as an adjunct to diet and exercise to improve
glycaemic control in adults with type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
and established cardiovascular disease.
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in
Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering
scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs
about 63,400 people in 80 countries and markets its products in around 170 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, Instagram, X, LinkedIn and YouTube.
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Contacts for further information
Media: |
|
Ambre James-Brown
+45 3079 9289
abmo@novonordisk.com |
Liz Skrbkova (US)
+1 609 917 0632
lzsk@novonordisk.com |
|
|
Investors: |
|
Daniel Muusmann Bohsen
+45 3075 2175
dabo@novonordisk.com |
Jacob Martin Wiborg Rode
+45 3075 5956
jrde@novonordisk.com |
|
|
David Heiberg Landsted
+45 3077 6915
dhel@novonordisk.com |
Mark Joseph Root (US)
+1 848 213 3219
mjhr@novonordisk.com |
|
|
Sina Meyer
+45 3079 6656
azey@novonordisk.com |
Frederik Taylor Pitter
+45 3075 8259
fptr@novonordisk.com |
| 1. | Based on treatment policy estimand: treatment
effect regardless of treatment adherence |
| 2. | eGFR: estimated glomerular filtration
rate |
| 3. | CKD-EPI: Chronic Kidney Disease Epidemiology
Collaboration |
Novo Nordisk A/S Investor Relations | Novo Alle 1 2880 Bagsværd Denmark | Telephone: +45 4444 8888 | Internet:
www.novonordisk.com CVR no:
24 25 67 90 |
| | | Company
announcement No 20 / 2024 |
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 5, 2024 |
NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer |
Novo Nordisk (NYSE:NVO)
過去 株価チャート
から 4 2024 まで 5 2024
Novo Nordisk (NYSE:NVO)
過去 株価チャート
から 5 2023 まで 5 2024