Novo Nordisk A/S: Wegovy® recommended by the European regulatory
authorities for label update to reflect reduced heart failure
symptoms and improved physical function
Wegovy®
recommended by the European regulatory authorities for
label update to reflect reduced heart failure symptoms and improved
physical function
- Wegovy® (semaglutide 2.4 mg) is the first obesity
medication to receive a positive opinion recommending a label
update that reflects reduced symptoms and improved physical
limitations and exercise function in people with obesity-related
heart failure with preserved ejection fraction (HFpEF).
- The positive opinion is based on results from the STEP HFpEF
and STEP HFpEF-DM trials, which showed that Wegovy® is
an effective therapy compared to placebo for people with
obesity-related HFpEF.1,2
Bagsværd, Denmark, 19 September 2024 – Novo
Nordisk today announced that the European Medicines Agency’s (EMA)
Committee for Medicinal Products for Human Use (CHMP) has adopted a
positive opinion for an update of the Wegovy®
(semaglutide 2.4 mg) label in the European Union (EU). The label
update incorporates data showing that Wegovy®, when
added to standard of care, can reduce heart failure-related
symptoms and improve physical limitations and exercise function in
people with obesity-related HFpEF, with or without type 2
diabetes.1,2
The positive opinion is based on the results from the STEP HFpEF
and STEP HFpEF-DM trials conducted in people with obesity-related
HFpEF, with or without type 2 diabetes. 1,2 In both
trials, Wegovy® demonstrated greater reductions in heart
failure-related symptoms and greater improvements in physical
limitations, as measured by the patient-reported Kansas City
Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS),
alongside greater weight loss compared to placebo.1,2
The beneficial effects were consistent regardless of baseline age,
sex, race, ethnicity, body mass index (BMI), region, systolic blood
pressure, left ventricular ejection fraction, and concomitant heart
failure therapy.1,2
The label update also incorporates data which showed that
participants receiving Wegovy® achieved a greater
increase in exercise function, as measured by the difference in
6-minute walking distance (6MWD) from baseline to week 52, compared
to those receiving placebo.1,2
“The recommendation to update the EMA label for
Wegovy® is an important step forward for people with
obesity-related HFpEF who currently have limited treatment options.
Wegovy® improves patients’ health-related quality of
life, enabling them to live a life with greater functionality to
conduct daily activities. These data further add to the body of
evidence for the semaglutide molecule,” said Martin Holst Lange,
executive vice president and head of Development at Novo
Nordisk.
The recommendation to incorporate the data from the STEP HFpEF
trials adds to the recent Wegovy® EMA label update that
included data from the SELECT landmark trial to reflect risk
reduction of heart attack, stroke and cardiovascular
death.3
With the positive opinion from the CHMP, Novo Nordisk expects
implementation of the EU label update shortly, following a
linguistic review process by the EMA. As communicated earlier this
year, Novo Nordisk will resubmit to the US Food & Drug
Administration for inclusion of data from the STEP HFpEF trials in
the Wegovy® label in the US in 2025.
About HFpEF and obesity
Heart failure affects at least 64 million people worldwide and is
especially prevalent in those with obesity and/or type 2
diabetes.3 Heart failure with preserved ejection
fraction (HFpEF) is now the most common form of heart failure,
comprising approximately 50% of all heart failure
cases.4,5 Obesity is considered a key driver in the
development and progression of HFpEF.6 Approximately 80%
of people with HFpEF live with overweight or obesity, which is
associated with symptoms including shortness of breath, swollen
legs and feet and trouble exercising.7,8 This can lead
to poor quality of life due to the greater symptom burden and worse
physical functioning.9 Despite therapeutic advances in
HFpEF, significant unmet needs persist.10
About STEP HFpEF and STEP HFpEF-DM trials
The primary objective of STEP HFpEF and STEP HFpEF-DM trials was to
investigate the effects of subcutaneous semaglutide 2.4 mg
once-weekly on symptoms, physical function, and body weight
compared with placebo in patients with obesity-related
HFpEF.11 STEP HFpEF included 529 people with HFpEF
(ejection fraction ≥45%) and obesity (BMI ≥30
kg/m2),2 while STEP HFpEF-DM included 616
people with HFpEF (ejection fraction ≥45%), obesity (BMI ≥30
kg/m2) and type 2 diabetes.1 Both trials had
dual primary endpoints: change in the Kansas City Cardiomyopathy
Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to
week 52 and change in body weight from baseline to week
52.1,2 Key secondary endpoints included change in
6-minute walking distance (6MWD), a hierarchical composite endpoint
(all-cause death, heart failure events, changes in KCCQ-CSS and
6MWD from baseline to week 52), and changes in C-reactive protein
from baseline (screening) to week 52. 1,2
About Wegovy®
(semaglutide 2.4 mg)
In the EU, Wegovy® is indicated as an adjunct
to a reduced calorie diet and increased physical activity for
weight management in adults with a BMI of 30 kg/m2 or
greater (obesity), or adults with a BMI of 27 kg/m2 or
greater (overweight) in the presence of at least one weight-related
comorbid condition.12 In the EU, Wegovy® is
also indicated for paediatric patients aged 12 years and older with
an initial BMI at the 95th percentile or greater for age
and gender (obesity) and body weight above 60 kg.12 In
addition to this, the Wegovy® label (clinical data
section) in the EU also reflects data on risk reduction of major
adverse cardiovascular events (MACE) in adults with established
cardiovascular disease and either overweight or obesity (initial
BMI ≥27 kg/m2) without diabetes.3
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 69,000 people
in 80 countries and markets its products in around 170 countries.
For more information, visit novonordisk.com,
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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: |
|
Jacob
Martin Wiborg Rode
+45 3075 5956
jrde@novonordisk.com
|
David
Heiberg Landsted
+45 3077 6915
dhel@novonordisk.com
|
Sina
Meyer
+45 3079 6656
azey@novonordisk.com
|
Frederik
Taylor Pitter
+1 609 613 0568
fptr@novonordisk.com
|
Ida Schaap
Melvold
+45 3077 5649
idmg@novonordisk.com
|
Mark
Joseph Root (US)
+1 848 213 3219
mjhr@novonordisk.com
|
References
1) Kosiborod MN, Petrie MC, Borlaug BA, et
al. Semaglutide in Patients with Obesity-Related Heart Failure
and Type 2 Diabetes. N Engl J Med. 2024;
390:1394-1407.
2) Kosiborod MN, Abildstrom SZ, Borlaug BA,
et al. Semaglutide in Patients with Heart Failure with
Preserved Ejection Fraction and Obesity. N Engl J Med.
2023; 389:1069-1084.
3) Borlaug BA, Jensen MD, Kitzman DW, et
al. Obesity and heart failure with preserved ejection
fraction: new insights and pathophysiological targets.
Cardiovasc Res. 2023; 118:3434-3450.
4) Gurwitz JH, Magid DJ, Smith DH, et
al. Contemporary prevalence and correlates of incident heart
failure with preserved ejection fraction. Am J Med. 2013;
126:393-400.
5) Haass M, Kitzman DW, Anand IS, et
al. Body mass index and adverse cardiovascular outcomes in
heart failure patients with preserved ejection fraction: results
from the Irbesartan in Heart Failure with Preserved Ejection
Fraction (I-PRESERVE) trial. Circ Heart Fail. 2011;
4:324-331.
6) Koliaki C, Liatis S and Kokkinos A. Obesity
and cardiovascular disease: revisiting an old relationship.
Metabolism. 2019; 92:98-107.
7) Reddy YNV, Rikhi A, Obokata M, et
al. Quality of life in heart failure with preserved ejection
fraction: importance of obesity, functional capacity, and physical
inactivity. Eur J Heart Fail. 2020; 22:1009-1018.
8) Gevaert AB, Kataria R, Zannad F, et
al. Heart failure with preserved ejection fraction: recent
concepts in diagnosis, mechanisms and management. Heart.
2022; 108:1342-1350.
9) Yap J, Tay WT, Teng TK, et al.
Association of Diabetes Mellitus on Cardiac Remodeling, Quality of
Life, and Clinical Outcomes in Heart Failure With Reduced and
Preserved Ejection Fraction. J Am Heart Assoc. 2019;
8:e013114.
10) Borlaug BA, Jensen MD, Kitzman DW, et
al. Obesity and heart failure with preserved ejection
fraction: new insights and pathophysiological targets.
Cardiovasc Res. 2023; 118:3434-3450.
11) ClinicalTrials.gov. Research Study to Look
at How Well Semaglutide Works in People Living With Heart Failure,
Obesity and Type 2 Diabetes (STEP HFpEF DM). Available at:
https://clinicaltrials.gov/ct2/show/NCT04916470. Last accessed:
September 2024.
12) European Medicines Agency. Wegovy: EPAR -
Product Information. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/wegovy#product-details.
Last accessed: September 2024.
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