News | FDA | March 08, 2024

FDA Approves Wegovy for Cardiovascular Risk Reduction in Adults with Known Heart Disease and Overweight or Obesity

The approval is based on the results of SELECT, the largest cardiovascular outcomes trial ever completed for people with obesity and known heart disease

The approval is based on the results of SELECT, the largest cardiovascular outcomes trial ever completed for people with obesity and known heart disease

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March 8, 2024 — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an additional indication for Wegovy (semaglutide) 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

"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

The FDA also released a statement about its new approved indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. Wegovy should be used in addition to a reduced calorie diet and increased physical activity. Cardiovascular disease is a group of diseases of the heart and blood vessels. 

“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a statement issued by the FDA. “This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.” 

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

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.

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 

For more information: WegovySupply.com

References:

  1. Wegovy (semaglutide) injection 2.4 mg Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; 2024.
  2. 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.
  3. 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.
  4. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed February 2024. Available at: https://www.cdc.gov/obesity/data/adult.html.
  5. 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#.
  6. 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.
  7. 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.
  8. 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.
  9. Centers for Disease Control and Prevention. Causes of Obesity. Last accessed: February 2024. Available at: https://www.cdc.gov/obesity/basics/causes.html.
  10. World Obesity Federation. World Obesity Atlas 2023. Last accessed: February 2024.Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023.
  11. 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.
  12. 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.
  13. MillionHearts. Costs & Consequences. Last accessed: February 2024. Available at: https://millionhearts.hhs.gov/learn-prevent/cost-consequences.html.
  14. 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.
  15. 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.
  16. 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.
  17. 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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