The Food and Drug Administration (FDA) has recently granted approval for Novo Nordisk’s weight loss drug, Wegovy, to be used in reducing the risk of serious cardiovascular complications in adults with obesity and heart disease. This decision is expected to have a significant impact on insurance coverage for the drug, making it more accessible to patients who previously faced barriers in obtaining it due to its high cost.
Wegovy, which is already widely used by millions of patients, has been proven to have health benefits beyond weight loss and blood sugar regulation. In a landmark late-stage trial, weekly injections of Wegovy were found to reduce the overall risk of heart attack, stroke, and death from cardiovascular causes by 20%. This makes Wegovy the first weight loss medication to gain expanded approval for this purpose.
Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, emphasized the significance of this approval for public health. Adults with obesity and heart disease are at a higher risk of cardiovascular complications, and providing them with a treatment option that can effectively lower that risk is a major advancement.
The FDA recommends that Wegovy be used in conjunction with a reduced calorie diet and increased physical activity. This combination approach has shown promising results in reducing the risk of cardiovascular events.
Wegovy belongs to a class of drugs that mimic a hormone called GLP-1, which is produced in the gut and helps suppress appetite. Its popularity has soared in recent years, leading to shortages in supply. The drug, along with its lower-dose diabetes counterpart Ozempic, costs around $1,000 per month before insurance coverage.
Novo Nordisk, the pharmaceutical company behind Wegovy, expressed its excitement about the FDA’s approval. They view it as a pivotal step forward in addressing pressing health issues. The company is also working on increasing its manufacturing capacity to ensure a responsible supply of this important medicine. Novo Nordisk expects to receive a similar approval for Wegovy in the European Union later this year.
The FDA’s decision was based on the results of a landmark phase three trial called SELECT. This study involved approximately 17,500 participants with obesity and heart disease, excluding those with diabetes. Over the course of five years, Wegovy demonstrated a 28% reduction in the risk of non-fatal heart attacks and a smaller 7% reduction in non-fatal strokes. However, it is worth noting that the trial had limited diversity, with the majority of participants being male and white.
While Wegovy has shown promising results in reducing cardiovascular events, it does come with some side effects. Nearly 17% of participants in the trial discontinued the drug due to gastrointestinal issues such as vomiting and diarrhea, which occurred at a higher rate compared to those on the placebo.
Novo Nordisk’s approval for Wegovy puts them ahead of their competitor, Eli Lilly, whose weight-loss drug Zepbound was approved in the U.S. in November. Although Zepbound has been proven to help people lose more weight, it has yet to demonstrate an effect on cardiovascular outcomes.
Overall, the FDA’s approval of Wegovy for reducing cardiovascular complications in adults with obesity and heart disease marks a significant milestone in the field of weight loss medications. It provides hope for patients who have struggled with access to effective treatments and highlights the potential health benefits beyond weight loss that these drugs can offer. With Novo Nordisk’s commitment to increasing manufacturing capacity, it is expected that more patients will be able to benefit from this groundbreaking medication in the near future.
