Potential FDA Approval of Weight-Loss Drug Wegovy as a Treatment to Reduce Cardiovascular Disease Risk

Published on November 10, 2023, 12:52 am

Potential FDA Approval of Weight-Loss Drug Wegovy as a Treatment to Reduce Cardiovascular Disease Risk

Novo Nordisk, the manufacturer of the weight-loss drug Wegovy (semaglutide), has announced that they could receive expanded approval from the U.S. Food and Drug Administration (FDA) to market the medication as a treatment to reduce cardiovascular disease risk. Chief Financial Officer Karsten Munk Knudsen shared in an interview with CNBC on “Street Signs” that the FDA could provide its stamp of approval within six months.

One significant outcome of this potential approval is that insurance coverage for Wegovy may become more prevalent. Many insurance providers have been stopping coverage for this highly sought-after obesity drug due to its cost. Expanding insurance coverage would be a welcome development for patients.

Dr. Michael Wesley Milks, a cardiologist at The Ohio State University Wexner Medical Center, explained that drugs like Wegovy belong to a class called “GLP-1 receptor agonists.” These drugs are believed to stimulate insulin production in response to eating, leading to a decline in blood sugar and a reduction in how quickly the stomach empties. This helps people feel more satisfied and eat less, resulting in weight loss.

According to Dr. Milks, GLP-1 receptor agonists may also have other beneficial effects such as reducing inflammation, salt retention propensity, and blood pressure. These effects can translate into positive cardiovascular health outcomes. Additionally, lowered blood sugar is believed to be beneficial for reducing the risk of heart attacks and strokes.

A recent study called SELECT tested GLP-1 receptor agonists among a group of patients without diabetes but with elevated risk factors for heart disease such as obesity. The study involved 17,604 overweight or obese individuals aged 45 and older who received once-weekly subcutaneous injections of semaglutide in addition to standard care for up to five years. The late-stage data from the study showed that Wegovy reduced the risk of major cardiovascular events by 20% compared to a placebo.

Dr. Milks commented that the amount of weight loss alone cannot fully account for the degree of risk reduction seen in the study. This suggests that other factors may have played a role in the positive outcomes.

In light of these findings, Dr. Milks advised patients to discuss heart and vascular disease risks with their primary care providers, whether or not they consider using Wegovy or other medications. He emphasized the importance of efforts to optimize blood pressure, blood sugar, body weight, and cholesterol values through dietary improvements, increased physical activity, and possible medication use.

If considering medication as part of their weight management journey, individuals should consult with a doctor specializing in weight management and cardiovascular care. Dr. Banita Sehgal, an Internal Medicine Physician with 20 years of experience, recommends a holistic approach to weight loss that includes increased physical activity and a heart-healthy diet. She advises patients to undergo a comprehensive medical evaluation to determine the most suitable and effective treatment plan for them as individuals.

Assessing the cost aspect, Dr. Alex Foxman, medical director of Achieve Health and Weight Loss, mentioned that while Wegovy can be expensive (approximately $1,300 per month without insurance), many Americans with insurance pay significantly less than $25 per month for the drug if they meet coverage criteria. This indicates that most major pharmacy benefit managers and health plans are still covering Wegovy, potentially making about 50 million Americans with obesity eligible for coverage under their health plans.

At present, Wegovy is FDA-approved for chronic weight management in adults with obesity or overweight who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. However, coverage may vary depending on individual insurance companies.

In summary,…