Image credit: Aquir | stock.Adobe.com

The FDA says that along with a reduced-calorie diet and increased physical activity, Novo Nordisk’s Wegovy ( The indications for semaglutide have been expanded.¹

Wegovy, a glucagon-like peptide-1 (GLP-1) receptor agonist, is being shown in 2021 for chronic weight management in people who are obese or overweight and have at least one weight-related disease, such as hypertension and type 2 diabetes. It was first approved in June. , or high cholesterol, in addition to increased diet and exercise. Semaglutide 1 mg injection (Ozempic) was first approved to treat his type 2 diabetes in 2017.²

Doug Langa, executive vice president, head of North American operations and president of Novo Nordisk, said: “Today, we are adding indications for Wegoby, making it an extremely important candidate for addressing some of the most pressing health issues of our time. “We have taken an important step.” said in a press release. “We recognize how important this moment is for the millions of people living with overweight, obesity and known heart disease, and we are committed to making options that put their needs first. Mitigating this risk is a key part of our approach to motoring. We are committed to increasing our manufacturing capabilities to responsibly supply this important medicine. and make a difference in this community. ”¹

This regulatory action is based on the results of the landmark, multicenter, randomized, double-blind, placebo-controlled, event-driven Phase III SELECT (Effects of Semaglutide on Cardiovascular Outcomes in Overweight or Obese People) trial. It was based on. This study compared His Wegovy with a placebo at a dose of 2.4 mg as an adjunct to standard of care in individuals with a history of cardiovascular disease, overweight or obesity, and no history of diabetes. We analyzed its effectiveness in reducing the risk of The researchers enrolled 17,604 adults at her more than 800 research sites in 41 countries.

Trial data shows that Wegovy significantly reduces the risk of an initial three-part composite MACE endpoint consisting of cardiovascular death, non-fatal heart attack, or non-fatal stroke. The trial’s primary composite outcome occurred in 6.5% of the group receiving Wegovy and 8.0% in the placebo cohort.

The estimated relative risk reduction for MACE was 20% compared to placebo (HR 0.80 [95% CI: 0.72, 0.90] p <0.001, absolute risk reduction of 1.5% over mean follow-up of 40 months). The study found that Wegovy's reduction in MACE was not affected by age, gender, race, ethnicity, baseline BMI, or renal impairment.

From a safety perspective, 16% of patients receiving Wegovy discontinued treatment due to adverse events (AEs), compared to 8% in the placebo cohort. The most common AE leading to discontinuation was gastrointestinal upset, reported in 10% of patients in the Wegovy cohort and 2% in the placebo cohort.

Wegovy includes an in-box warning to inform healthcare professionals and patients about the potential risks of thyroid C-cell tumors. GLP-1 receptor agonists should not be administered to individuals with a personal or family history of medullary thyroid cancer or to patients with multiple endocrine tumor syndrome type 2.²

In addition to the latest approval, Wegovy can be used in combination with a reduced-calorie diet and increased physical activity for obese people aged 12 years and older, or adults who are overweight and have weight-related medical problems. It is indicated for reducing excess weight.

“People who are overweight or obese, have cardiovascular disease, and do not have diabetes have not previously received FDA-approved treatment options that reduce weight and reduce the likelihood of another cardiovascular event. , this approval is an important decision,” said Mr. A, lead author of the SELECT study. “For medical professionals, this approval is a great opportunity for new treatments to help address the residual cardiovascular risks that remain in patients receiving current standard of care,” Michael Linkoff, M.D., professor of medicine at the Cleveland Clinic, said in a press release. “It provides options.”¹

References

1. Wegovy® is FDA approved for cardiovascular risk reduction in adults with known heart disease and overweight or obesity. Novo Nordisk. news release. March 8, 2024. Accessed March 8, 2024. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=167031

2. FDA approves first new drug treatment for chronic weight management since 2014. F.D.A. news release. June 4, 2012. Accessed March 8, 2024. https://www.fda.gov/news-events/press-payments/fda-approves-new-drug-treatment-chronic-weight-management-first-2014