Semaglutide (Wigoby, Novo Nordisk) was approved on Friday, as the FDA expanded its approved use to include the prevention of cardiovascular death, myocardial infarction, and stroke in adult patients with cardiovascular disease (CVD) and overweight or obesity. Obtained new adaptations.¹

This new indication was approved through a priority review process and is based on results from the SELECT cardiovascular outcomes trial (NCT03574597).² SELECT findings show that adding semaglutide to standard care increases the risk of major cardiovascular events (MACE) (cardiovascular death, non-fatal myocardial infarction (heart attack), non-fatal stroke) by 20% compared to placebo. % was shown to decrease significantly.

FDA approved | Image credit: © chrisdorney – Stock.adobe.com

“This expanded indication is a major step forward in the treatment of obesity and prevention of its cardiovascular effects,” said Dr. Ian Kneeland. American Managed Care Journal® (AJMC®). “This increases the likelihood of expanding access and, hopefully, improving insurance coverage to this important treatment option for millions of people at risk.” He is the Director of Vascular Prevention and Co-Director of the Center for Integrative and Novel Approaches in Vascular Metabolic Diseases at University Hospital Harrington Heart and Vascular Institute, and Associate Professor of Medicine at Case Western Reserve University School of Medicine.

Semaglutide was first approved by the FDA in June 2021, making it the first new drug to be approved for chronic weight management since 2014.³ At the time, it was indicated only for chronic weight management in obese or overweight adults with at least one weight-related disease, such as high blood pressure, type 2 diabetes, or high cholesterol. In December 2022, eligibility was expanded to include pediatric patients 12 years of age and older whose BMI for age and gender is at least the 95th percentile.^Four Similar to the original approval, the new expanded indication specifies that semaglutide injections should be used in addition to reducing calories and increasing physical activity.¹

In this multicenter, double-blind SELECT trial, more than 17,600 participants will receive standard treatments to manage blood pressure and cholesterol, as well as stay healthy if needed, according to an FDA news release. They were randomly assigned to receive either semaglutide or a placebo. lifestyle, such as diet and activity;¹ Participants were 45 years of age or older, had an established diagnosis of CVD, but had no history of diabetes within the past 5 years.²

The MACE endpoint occurred in 6.5% of participants receiving semaglutide versus 8% of participants receiving placebo.¹ The reduction in MACE risk was seen regardless of baseline age, sex, race, ethnicity, BMI, and renal impairment.² Semaglutide was associated with a 15% reduction in the risk of cardiovascular death and a 19% reduction in the risk of all-cause mortality compared with placebo, in addition to a 20% reduction in combined effect.²

Wegovy, a 2.4 mg injection, is part of the glucagon-like peptide 1 (GLP-1) receptor agonist class, which also includes 0.5, 1, or 2 mg injection semaglutide (Ozempic), which is approved for blood sugar control. included. Adults with type 2 diabetes. With the increasing use of Ozempic, Wigovy, and Semaglutide (Liversus) for weight loss, shortages have been reported over the past year, leaving some diabetics without access to the drugs.^Five

At the same time, employers and health insurance companies are grappling with how to cover and pay for these medications given the large number of eligible beneficiaries. On Thursday, Cigna announced the launch of a program through the company’s Pharmacy Benefits Management division that guarantees customers a 15% cap on annual cost increases for these treatments by directing patients to lifestyle modification and coaching support. announced the increase. “Guarantee” for clients interested in covering GLP-1 receptor agonists.⁶

The prescribing information for semaglutide includes a boxed warning to inform health care professionals and patients about the risk of thyroid C-cell tumors.¹

“Wegovy is the first weight loss drug approved for use in the prevention of life-threatening cardiovascular events in obese or overweight adults with cardiovascular disease,” said Dr. says John Sharetz, MD. at the FDA’s Center for Drug Evaluation and Research, the FDA said in a news release.¹ “This patient population is at increased risk for cardiovascular death, heart attack, and stroke. Providing treatment options proven to reduce this cardiovascular risk is a major advance for public health.”

References

1. The FDA has approved the first treatment to reduce the risk of serious heart disease, especially in adults who are obese or overweight. news release. F.D.A. March 8, 2024. Accessed March 8, 2024. https://www.fda.gov/news-events/press-payments/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specially- Adults -obesity- or

2. Wegovy® was approved in the United States to reduce cardiovascular risk in people who are overweight or obese and have cardiovascular disease. news release. Novo Nordisk. March 8, 2024. Accessed March 8, 2024. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=167030

3. Inserro I. The FDA has approved the use of semaglutide for weight loss when combined with diet and exercise. AJMC. June 4, 2021. Accessed March 8, 2024. https://www.ajmc.com/view/fda-clears-semaglutide-for-weight-loss-when-used-with-diet-exercise

4. FDA approves once-weekly Wegovy injection to treat obesity in teens 12 and older. news release. Novo Nordisk. December 23, 2022. Accessed May 18, 2023. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=151389

5. Klein HE The ongoing crisis: Semaglutide shortages pose dual concerns for the treatment of obesity and diabetes. AJMC. December 21, 2023. Accessed March 8, 2024. https://www.ajmc.com/view/an-oncoming-crisis-semaglutide-shortage-raises-dual-concerns-for-obesity-and-diabetes-treatment

6. AJMC staff. What we’re reading: FDA delays decision on donanemab. Cost of Weight Loss Drugs. Effective RSV treatment. AJMC. March 8, 2024. Accessed March 8, 2024. https://www.ajmc.com/view/what-we-re-reading-fda-lays-decision-on-donanemab-weight-loss-drug-costs-Effective-rsv-treatment