- Semaglutide 1 mg demonstrated a statistically significant
and superior reduction of 24% in the risk of kidney disease-related
events vs. placebo in adults with type 2 diabetes and chronic
kidney disease.
- Based on FLOW trial data, Novo Nordisk submitted a label
extension application for Ozempic®, which
has been accepted for review by the FDA.
PLAINSBORO, N.J., June 24,
2024 /PRNewswire/ -- Novo Nordisk today presented the
full results from FLOW, its phase 3b
kidney outcomes trial investigating the effects of once-weekly
injectable semaglutide 1 mg in adults with type 2 diabetes and
chronic kidney disease (CKD), at the 84th Annual
Scientific Sessions of the American Diabetes Association (ADA). The
double-blind, randomized, placebo-controlled trial, which enrolled
3,533 people with type 2 diabetes and CKD, achieved its primary
endpoint, with semaglutide 1 mg demonstrating a 24% reduction in
the risk of kidney disease progression and cardiovascular and
kidney mortality compared to placebo (331 vs. 410 events; hazard
ratio: 0.76 [0.66; 0.88]; P=0.0003).1 The primary
outcome was major kidney disease events, a composite of onset of
kidney failure (initiation of long-term dialysis, kidney
transplantation, or a reduction in the eGFR to <15 ml per minute
per 1.73 m2 sustained for
≥28 days), a sustained (for ≥28 days) 50% or greater reduction in
eGFR from baseline, or death from kidney-related or cardiovascular
causes.1
"Treating serious comorbidities like chronic kidney disease is
critical to improving treatment outcomes for people with type 2
diabetes. The results from the FLOW trial represent important data,
as we look to better understand what GLP-1 treatment options could
mean for this patient population," said Anna Windle, PhD, senior vice president clinical
development, Medical & Regulatory Affairs at Novo Nordisk.
"Leveraging our deep expertise in cardiometabolic science, we are
proud to continue building strong clinical evidence on the strength
and versatility of semaglutide to deliver results for people living
with serious chronic diseases."
Additionally, the study found that semaglutide 1 mg demonstrated
superiority to placebo for all confirmatory secondary outcomes
assessed, including a significant reduction in the mean annual
glomerular filtration rate (eGFR) slope by 1.16 ml/min/1.73 m²/year
(−2.19 vs. −3.36 ml/min/1.73 m²/year [0.86; 1.47]; P<0.001). The
risk of major cardiovascular events was significantly lower in the
semaglutide group than in the placebo group (212 vs. 254 events;
hazard ratio: 0.82; [0.68; 0.98]; P=0.029). The risk of death from
any cause was significantly lower in the semaglutide group than in
the placebo group (227 vs. 279 events; hazard ratio: 0.80 [0.67;
0.95]; P=0.01).1
Serious adverse events were reported in fewer participants in
the semaglutide group than in the placebo group (877 [49.6%] vs.
950 [53.8%]). Prespecified adverse events of special interest (≥5%)
for participants in the semaglutide and placebo groups,
respectively, included diabetic retinopathy (402 [22.8%] vs. 398
[22.5%], Covid-19-related disorder (358 [20.3%] vs. 404 [22.9%]),
serious cardiovascular disorder (273 [15.4%] vs. 319 [18.1%], heart
failure (133 [7.5%] vs. 175 [9.9%]), acute kidney failure (172
[9.7% vs. 182 [10.3%]), malignant tumor (120 [6.8%] vs. 104 [5.9%])
and serious gastrointestinal disorder (95 [5.4%] vs. 94 [5.3%]).
Adverse events leading to permanent discontinuation of semaglutide
or placebo were more common in the semaglutide group than in the
placebo group (233 [13.2%] vs. 211 [11.9%]); this finding was
driven mainly by discontinuation because of gastrointestinal
disorders (79 [4.5%] vs. 20 [1.1%]).1
Novo Nordisk stopped the FLOW study early based on a
recommendation from an Independent Data Monitoring Committee due to
meeting pre-specified efficacy criteria after a median follow-up of
3.4 years.
Based on data from the FLOW clinical trial, Novo Nordisk
submitted a label extension application
for Ozempic®, which has been accepted for review by
the U.S. Food & Drug Administration (FDA). A decision is
anticipated in January 2025. Data from the FLOW trial were
previously presented in May at the 61st European Renal
Association Congress and simultaneously published in the New
England Journal of Medicine.1
About FLOW
FLOW was an international, randomized, double-blind,
parallel-group, placebo-controlled, event-driven superiority trial
comparing injectable semaglutide 1 mg with placebo as an adjunct to
standard of care on kidney outcomes for reducing the risk 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 (1,767 in the semaglutide group and 1,766 in the placebo
group) were enrolled in the trial conducted in 28 countries at
around 400 investigator sites. The FLOW trial was initiated in
2019.1
The key objective of the FLOW trial was to demonstrate delay in
the progression of CKD and a lower 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 included annual rate of change in
eGFR (CKD-EPI), MACE (non-fatal myocardial infarction,
non-fatal stroke, cardiovascular death) and all-cause
death.1
About CKD
CKD affects more than 800 million people worldwide2,
and its prevalence is expected to rise with an aging demographic
and increasing incidence of diabetes. CKD is a common complication
of type 2 diabetes, with approximately 40% of people with type 2
diabetes also experiencing CKD.3 For people with type 2
diabetes, CKD imparts a considerable burden and is a major cause of
morbidity, including increased cardiovascular risk and
mortality.4
Despite the availability of effective therapies, a significant
residual risk of CKD progression and cardiovascular events remains
in people with type 2 diabetes.5
About Ozempic®
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2
mg is a once-weekly glucagon-likepeptide-1 (GLP-1) receptor agonist
indicated along with diet and exercise to improve blood sugar
(glucose) in adults with type 2 diabetes and to reduce the risk of
major cardiovascular events such as heart attack, stroke, or death
in adults with type 2 diabetes with known heart disease.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been
making innovative medicines to help people with diabetes lead
longer, healthier lives for more than 100 years. This heritage has
given us experience and capabilities that also enable us to drive
change to help people defeat other serious chronic diseases such as
obesity, rare blood, and endocrine disorders. We remain steadfast
in our conviction that the formula for lasting success is to stay
focused, think long-term, and do business in a financially,
socially, and environmentally responsible way. With U.S.
headquarters in New Jersey and
commercial, production and research facilities in seven states plus
Washington DC, Novo Nordisk
employs approximately 8,000 people throughout the country. For more
information, visit novonordisk-us.com, Facebook, Instagram, and
X.
Novo Nordisk is committed to the responsible use of our
semaglutide-containing medicines which represent distinct products
with different indications, dosages, prescribing information,
titration schedules, and delivery forms. These products are not
interchangeable and should not be used outside of their approved
indications.
Contacts for further information
Media:
|
|
Allison Schneider
(US)
+1 732 513 4875 (Mobile)
aocd@novonordisk.com
|
Ambre James-Brown
(Global)
+45 3079 9289 (Direct)
abmo@novonordisk.com
|
|
|
|
|
_______________________
References
- Perkovic V, Tuttle KR, Rossing P, et al.. Effects of
semaglutide on chronic kidney disease in patients with type 2
diabetes. New England Journal of Medicine. 2024.
https://doi.org/10.1056/nejmoa2403347
- Kovesdy CP. Epidemiology of chronic kidney disease: an update
2022. Kidney Int Suppl. 2022. 12(1): 7–11.
https://doi.org/10.1016/j.kisu.2021.11.003
- von Scholten BJ, Kreiner FF, Rasmussen S, Rossing P, Idorn T.
(2022). The potential of GLP-1 receptor agonists in type 2 diabetes
and chronic kidney disease: from randomised trials to clinical
practice. Ther Adv Endocrinol Metab. 2022; 13,
20420188221112490. https://doi.org/10.1177/20420188221112490
- de Boer IH, Rue TC, Hall YN, et al. Temporal trends in the
prevalence of diabetic kidney disease in the United States. JAMA.
2011;305:2532-9.
- de Boer IH, Khunti K, Sadusky T, et al. (2022). Diabetes
management in chronic kidney disease: a consensus report by the
American Diabetes Association (ADA) and Kidney Disease: Improving
Global Outcomes (KDIGO). Diabetes care. 2022; 45(12);
3075–3090. https://doi.org/10.2337/dci22-0027
Novo Nordisk is a registered trademark of Novo
Nordisk A/S.
© 2024 Novo Nordisk All rights reserved. US24OZM00325 June 2024
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