Novo Nordisk A/S: 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
05 März 2024 - 10:53AM
Novo Nordisk A/S: 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, major adverse cardiovascular events (MACE) and 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.”
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 FLOWFLOW 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.
Contacts for further information
Media: |
|
Ambre
James-Brown +45 3079 9289abmo@novonordisk.com |
Liz
Skrbkova (US)+1 609 917 0632lzsk@novonordisk.com |
Investors: |
|
Daniel
Muusmann Bohsen+45 3075 2175 dabo@novonordisk.com |
Jacob
Martin Wiborg Rode+45 3075 5956jrde@novonordisk.com |
David
Heiberg Landsted +45 3077 6915 dhel@novonordisk.com |
Mark
Joseph Root (US) +1 848 213 3219mjhr@novonordisk.com |
Sina
Meyer +45 3079 6656azey@novonordisk.com |
Frederik
Taylor Pitter +45 3075 8259fptr@novonordisk.com |
1. Based on treatment policy estimand: treatment effect
regardless of treatment adherence2. eGFR: estimated glomerular
filtration rate 3. CKD-EPI: Chronic Kidney Disease Epidemiology
Collaboration
Company announcement No 20 / 2024
- PR240305-FLOW-headline-results
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