- Wegovy® (semaglutide) injection 2.4 mg is the
first-and-only medicine indicated for both reduction of the risk of
major adverse cardiovascular events (MACE) such as death, heart
attack, or stroke and for long-term weight
management1
- The approval is based on the results of SELECT, the largest
cardiovascular outcomes trial ever completed for people with
obesity and known heart disease2
PLAINSBORO, N.J., March 8,
2024 /PRNewswire/ -- Novo Nordisk today announced
that the U.S. Food and Drug Administration (FDA) has approved an
additional indication for Wegovy® to reduce the risk of
major cardiovascular events such as death, heart attack, or stroke
in adults with known heart disease and with either obesity or
overweight along with a reduced calorie diet and increased physical
activity.1 This new indication adds to the
prescribing label for Wegovy®, a prescription-only
medicine previously approved help adults and children aged 12 years
and older with obesity, or some adults with overweight who also
have weight-related medical problems, to help them lose excess body
weight and keep the weight off when used along with a reduced
calorie diet and increased physical activity.1
Experience the full interactive Multichannel News Release here:
https://www.multivu.com/players/English/9253451-novo-nordisk-wegovy-semaglutide-fda-approval/
"Today, we're taking a pivotal step forward in addressing some
of the most pressing health issues of our time with the added
indication for Wegovy®," said Doug Langa, Executive Vice President, Head of
North America Operations, and President of Novo Nordisk Inc. "We
recognize how important this moment is for the millions of people
who live with excess weight or obesity and known heart disease, and
we will continue to advance options that put their needs first.
Reducing this risk is a key part of our commitment to driving
change for this community, as we work to increase manufacturing
capacity to responsibly supply this important medicine."
The FDA decision is based on the results of the landmark SELECT
phase 3 cardiovascular outcomes trial that examined the effect of
adding Wegovy® 2.4 mg or placebo to cardiovascular
standard of care in adults with overweight and obesity with
established CVD and without diabetes.2
Wegovy® 2.4 mg significantly reduced the risk for first
occurrence of a three-part composite MACE endpoint consisting of
cardiovascular death, non-fatal heart attack, or non-fatal
stroke.1,2 The primary composite outcome occurred in
6.5% of patients treated with Wegovy® and 8.0% with
placebo. The estimated relative risk reduction of MACE was 20% vs
placebo (HR 0.80 [95% CI: 0.72, 0.90] p <0.001, absolute risk
reduction of 1.5% at 40 months, the mean follow-up
duration).1,2 The reduction of MACE with
Wegovy® was not impacted by age, sex, race, ethnicity,
baseline BMI, or level of renal function
impairment.1,2
Safety data collection was limited to serious adverse events
(including death), adverse events leading to discontinuation, and
adverse events of special interest.1,2 In the SELECT
trial, the proportion of patients for whom serious adverse events
were reported was 33.4% in patients randomized to
Wegovy® 2.4 mg and 36.4% of patients receiving
placebo.2 Sixteen percent (16%) of
Wegovy®-treated patients and 8% of placebo-treated
patients, respectively, discontinued study drug due to an adverse
event.1 The most common adverse event leading to
discontinuation was gastrointestinal disorders, occurring in 10% of
patients in the Wegovy® group and 2% in the placebo
group.2
"This approval is a significant decision because people living
with excess weight or obesity and established cardiovascular
disease and without diabetes have never had an FDA-approved
treatment option that lowers weight and reduces the likelihood of
another cardiovascular event," said Dr. A. Michael Lincoff, Professor of Medicine at
Cleveland Clinic and the lead study author of the SELECT outcomes
trial. "For healthcare professionals, this approval provides a new
treatment option to help us address cardiovascular residual risk
that remains for patients on current standard of care."
Between 1999 and 2020, obesity-related cardiovascular disease
deaths tripled in the U.S., according to the American Heart
Association.3 In fact, more than one in three U.S.
adults live with obesity,4 one of the leading risk
factors contributing to heart disease and stroke.5
About the SELECT Trial
SELECT (Semaglutide
Effects on Cardiovascular Outcomes in People with Overweight or
Obesity) was a multicenter, randomized, double-blind,
placebo-controlled, event-driven superiority trial designed to
evaluate the efficacy of Wegovy® 2.4 mg versus placebo
as an adjunct to cardiovascular standard of care for reducing the
risk of major adverse cardiovascular events in people with
established CVD with overweight or obesity with no prior history of
diabetes.2
The trial, initiated in 2018, enrolled 17,604 adults and was
conducted in 41 countries at more than 800 investigator
sites.2
About Wegovy®
(semaglutide) injection 2.4 mg
What is
Wegovy®?
WEGOVY® (semaglutide) injection 2.4 mg is an
injectable prescription medicine used with a reduced calorie diet
and increased physical activity:
- to reduce the risk of major cardiovascular events such as
death, heart attack, or stroke in adults with known heart disease
and with either obesity or overweight.
- that may help adults and children aged 12 years and older with
obesity, or some adults with overweight who also have
weight-related medical problems, to help them lose excess body
weight and keep the weight off.
Wegovy® contains semaglutide and should not be
used with other semaglutide-containing products or other GLP-1
receptor agonist medicines.
It is not known if Wegovy® is safe and
effective for use in children under 12 years of age.
Important Safety
Information
What is the most important information I should know about
Wegovy®?
Wegovy®
may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your
healthcare provider if you get a lump or swelling in your neck,
hoarseness, trouble swallowing, or shortness of breath. These may
be symptoms of thyroid cancer. In studies with rodents,
Wegovy® and medicines that work like
Wegovy® caused thyroid tumors, including thyroid
cancer. It is not known if Wegovy® will cause
thyroid tumors or a type of thyroid cancer called medullary thyroid
carcinoma (MTC) in people
- Do not use Wegovy® if you or any of your
family have ever had a type of thyroid cancer called medullary
thyroid carcinoma (MTC) or if you have an endocrine system
condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN
2)
Do not use Wegovy® if:
- you or any of your family have ever had a type of thyroid
cancer called medullary thyroid carcinoma (MTC) or if you have an
endocrine system condition called Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2)
- you have had a serious allergic reaction to semaglutide or any
of the ingredients in Wegovy®
Before using Wegovy®, tell your
healthcare provider if you have any other medical conditions,
including if you:
- have or have had problems with your pancreas or kidneys
- have type 2 diabetes and a history of diabetic retinopathy
- have or have had depression, suicidal thoughts, or mental
health issues
- are pregnant or plan to become pregnant.
Wegovy® may harm your unborn baby. You should
stop using Wegovy® 2 months before you plan to
become pregnant
- are breastfeeding or plan to breastfeed. It is not known if
Wegovy® passes into your breast milk
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Wegovy® may
affect the way some medicines work and some medicines may affect
the way Wegovy® works. Tell your healthcare
provider if you are taking other medicines to treat diabetes,
including sulfonylureas or insulin. Wegovy® slows
stomach emptying and can affect medicines that need to pass through
the stomach quickly.
What are the possible side effects of
Wegovy®?
Wegovy®
may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using
Wegovy® and call your healthcare provider right
away if you have severe pain in your stomach area (abdomen) that
will not go away, with or without vomiting. You may feel the pain
from your abdomen to your back
- gallbladder problems. Wegovy® may
cause gallbladder problems, including gallstones. Some gallstones
may need surgery. Call your healthcare provider if you have
symptoms, such as pain in your upper stomach (abdomen), fever,
yellowing of the skin or eyes (jaundice), or clay-colored
stools
- increased risk of low blood sugar (hypoglycemia), especially
those who also take medicines for diabetes such as insulin or
sulfonylureas. This can be a serious side effect. Talk to your
healthcare provider about how to recognize and treat low blood
sugar and check your blood sugar before you start and while you
take Wegovy®. Signs and symptoms of low blood
sugar may include dizziness or light-headedness, blurred vision,
anxiety, irritability or mood changes, sweating, slurred speech,
hunger, confusion or drowsiness, shakiness, weakness, headache,
fast heartbeat, or feeling jittery
- kidney problems (kidney failure). In people who have
kidney problems, diarrhea, nausea, and vomiting may cause a loss of
fluids (dehydration), which may cause kidney problems to get worse.
It is important for you to drink fluids to help reduce your chance
of dehydration
- serious allergic reactions. Stop using
Wegovy® and get medical help right away, if you
have any symptoms of a serious allergic reaction, including
swelling of your face, lips, tongue, or throat; problems breathing
or swallowing; severe rash or itching; fainting or feeling dizzy;
or very rapid heartbeat
- change in vision in people with type 2 diabetes. Tell
your healthcare provider if you have changes in vision during
treatment with Wegovy®
- increased heart rate. Wegovy® can
increase your heart rate while you are at rest. Tell your
healthcare provider if you feel your heart racing or pounding in
your chest and it lasts for several minutes
- depression or thoughts of suicide. You should pay
attention to any mental changes, especially sudden changes in your
mood, behaviors, thoughts, or feelings. Call your healthcare
provider right away if you have any mental changes that are new,
worse, or worry you
The most common side effects of Wegovy®
may include: nausea, diarrhea, vomiting, constipation,
stomach (abdomen) pain, headache, tiredness (fatigue), upset
stomach, dizziness, feeling bloated, belching, low blood sugar in
people with type 2 diabetes, gas, stomach flu, heartburn, and runny
nose or sore throat.
Please see Medication Guide and Prescribing Information,
Including Boxed Warning, for Wegovy at
https://www.novo-pi.com/wegovy.pdf
About obesity and cardiovascular disease (CVD)
Obesity
is a serious chronic, progressive, and misunderstood disease that
requires long-term management.6,7,8 One key
misunderstanding is that this is a disease of lack of willpower,
when in fact there is underlying biology that may impede people
with obesity from losing weight and keeping it off.6,8
Obesity is influenced by a variety of factors, including genetics,
social determinants of health, and the environment.9
The prevalence of overweight and obesity is a public health
issue that has severe cost implications to healthcare
systems.10,11 In the U.S., about 42% of adults live with
obesity.4
CVD is the leading cause of death in the U.S.12 More
than 800,000 people die from CVD each year in the U.S. (1 in every
3 deaths) with about 160,000 of these deaths occurring in people
younger than 65 years.13 Obesity increases the risk of
developing high blood pressure or high blood cholesterol, both
contributing factors to CVD.14,15 Residual risk for
another cardiovascular event in people with obesity and known heart
disease remains despite treatment of known cardiovascular risk
factors such as high blood pressure and high cholesterol according
to standard of care treatments.16,17
Novo Nordisk's commitment to the obesity and
cardiovascular community is a long-term one, and we are
investing significantly to build capacity to meet increasing
demand. Please visit WegovySupply.com for the latest
information.
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.
Further information
References:
- Wegovy® (semaglutide) injection 2.4 mg Prescribing
Information. Plainsboro, NJ: Novo
Nordisk Inc.; 2024.
- Lincoff MA, Brown-Frandson K, Colhoun HM, et al. Semaglutide
and Cardiovascular Outcomes in Obesity without Diabetes. N Engl
J Med. 2023;389:2221-2232.
- Raisi‐Estabragh Z, Kobo O, Mieres JH, et al. Racial Disparities
in Obesity‐Related Cardiovascular Mortality in the United States: Temporal Trends From 1999
to 2020. J Am Heart Assoc. 2023;12:e028409.
- Centers for Disease Control and Prevention. Adult obesity
facts. Last accessed February 2024.
Available at: https://www.cdc.gov/obesity/data/adult.html.
- Centers for Disease Control and Prevention. Heart disease and
stroke. Last Accessed: February 2024.
Available
at: https://www.cdc.gov/chronicdisease/resources/publications/factsheets/heart-disease-stroke.htm#.
- Kaplan LM, Golden A, Jinnett K, et al. Perceptions of
barriers to effective obesity care: Results from the national
action study. Obesity. 2018;26(1):61-69.
- Bray GA, Kim KK, Wilding JPH; World Obesity Federation.
Obesity: a chronic relapsing progressive disease process. A
position statement of the World Obesity Federation. Obes
Rev. 2017;18(7):715-723.
- Garvey WT, Mechanick JI, Brett EM, et al. American association
of clinical endocrinologists and American College of Endocrinology
comprehensive clinical practice guidelines for medical care of
patients with obesity. Endocr Pract. 2016;22 Suppl
3:1-203.
- Centers for Disease Control and Prevention. Causes of Obesity.
Last accessed: February 2024.
Available
at: https://www.cdc.gov/obesity/basics/causes.html.
- World Obesity Federation. World Obesity Atlas 2023. Last
accessed: February 2024.Available
at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023.
- Centers for Disease Control and Prevention. Why it Matters.
Last accessed: February 2024.
Available
at: https://www.cdc.gov/obesity/about-obesity/why-it-matters.html.
- Centers for Disease Control and Prevention. Leading Causes of
Death. Last accessed: February 2024.
Available
at: https://www.cdc.gov/nchs/fastats/leading-causes-of-death.html.
- MillionHearts. Costs & Consequences. Last accessed:
February 2024. Available at:
https://millionhearts.hhs.gov/learn-prevent/cost-consequences.html.
- Centers for Disease Control and Prevention. Health Effects of
Overweight and Obesity. Last accessed: February 2024. Available
at: https://www.cdc.gov/healthyweight/effects/index.html.
- Centers for Disease Control and Prevention. Know Your Risk for
Heart Disease. Last accessed: February
2024. Available
at: https://www.cdc.gov/heartdisease/risk_factors.htm.
- Powell-Wiley, Tiffany M., et al. "Obesity and Cardiovascular
Disease: A Scientific Statement From the American Heart
Association." Circulation, vol. 143, no. 21, 25 May 2021.
- Dhindsa DS, et al. "The Evolving Understanding and Approach to
Residual Cardiovascular Risk Management." Frontiers in
Cardiovascular Medicine, vol. 7(88); 1-11, 5/13/2020.
10.3389/fcvm.2020.00088.
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SOURCE Novo Nordisk