Wegovy Receives FDA Nod: Weight-loss drug Has Transformative impact on Obesity and Heart Disease treatments!

Wegovy Receives FDA Nod | Credits: Reuters
Wegovy Receives FDA Nod | Credits: Reuters

United States: The Food and Drug Administration (FDA), in Friday’s approval, decided that Novo Nordisk’s breakthrough weight loss drug Wegovy is beneficial for patients suffering from obesity and heart disease by lowering the risk of cardiovascular complications.

Millions of patients rely on an injectable treatment, which is in popular use. Yet, the agency’s ruling also has the potential to expand insurance coverage for the drug, and for future treatments related to obesity, which has been a major obstacle to its access and use among patients.

Benefits of weight loss drugs

Moreover, it now appears weight loss drugs not only result in shedding excess pounds and normalizing blood glucose levels but also cover significant other health benefits.

The clinical trial conducted after the weekly injections of Wegovy showed a 20 percent decreased risk of heart attack, stroke, and death from cardiovascular causes, according to a landmark late-stage trial on the drug, CNBC News reported.

More about Wegovy drug

For the first time, Wegovy is the weight-loss treatment receiving the FDA’s expanded approval for this purpose, according to Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.

It was pointed out that adults with obesity and heart disease are at a high risk previously of cardiovascular complications, so there would be a major public health advance if there was treatment proven to lower that risk.

According to the FDA, Wegovy should be kept by patients together with a reduced-calorie diet and increased physical activity.

Low supply of drugs

Wegovy, along with Ozempic, a diabetes treatment of relatively low dose, quickly became inaccessible and shortage in supply due to their increasing more and more popular for keeping patients slimming down in the long run.

These medications, like another class of drugs that are called GLP-1 analogs, also affect the hormone that is produced in the gut which leads to the reduction of one’s appetite. Both Wegovy and Ozempic cost a whopping $1,000 monthly before insurance.

According to Novo Nordisk, the approval represents a “pivotal step forward in addressing some of the most pressing issues of our time.”

Moreover, the company stated that it is working to increase manufacturing capacity to “responsibly supply this important medicine.”

However, Novo Nordisk also expects to have a similar approval for Wegovy approval in the EU this year, CNBC News reported.

About the three-phase trial

FDA’s decision was made on the basis of pros founder trial called SELECT. The study was carried out with 17,500 people having obesity and cardiovascular risk factors who did not have diabetes.

Wegovy was shown to be effective in avoiding a non-fatal heart attack as a result of the five-year trial. It was able to cut down the risk by 28 percent. It, however, resulted in a lower 7 percent rate of non-fatal, if not rare, strokes total number that was observed in the study.

Similarly, Wegovy appeared to stop cardiovascular events, such as high blood pressure, within months after the participants started the drug. The gulf between the active drug and placebo became more obvious as the study progressed.

Limitation of trial

17 percent of subjects in the trial did not take Wegovy treatment as frequently, the major reason being gastrointestinal symptoms such as nausea and diarrhea. They stopped the drug twice as fast as those receiving the placebo.

Another drawback of the survey was that there was a lack of diversity. Almost 3/4 of the participants were male, and that was supplemented with even more who were white. A quarter of 4% represented the Blacks.

New findings could still keep Novo Nordisk on top of Eli Lilly who are waiting for Zepound to be approved in the U.S. Weight loss achieved with Zepbound seems to be the quality of the weight loss rather than the quantity, but there is no evidence highlighting the benefit of the drug on the cardiovascular outcome, CNBC News reported.