Novo Nordisk A/S (NVO)

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Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity

Source: PR Newswire (US)
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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