FDA approves Wegovy weight-loss shot for heart disease patients – including those who are not obese
Adults with heart disease can now get a Wegovy prescription to reduce their risk of heart attack or stroke, even if they are not obese.
The FDA approved the drug for this use in non-diabetic adults after large-scale studies showed the drug reduced the risk of heart-related complications by as much as 28 percent.
The agency added that Wegovy – which uses the active ingredient semaglutide – should be used in addition to a reduced-calorie diet and increased physical activity in people who are overweight or obese.
Shares in Novo Nordisk, the drug’s owner, rose to $566 billion yesterday, making it the twelfth most valuable company in the world, after it unveiled a new drug that could lead to weight loss twice as fast as Ozempic.
The FDA approved the drug for this use in non-diabetic patients today, after clinical trials found it reduced the risk by as much as 28 percent
Wegovy – which uses the drug semaglutide – was already approved for use in overweight or obese patients to lose weight.
Its sister drug Ozempic, which uses lower doses of the same drug, is currently only approved for patients with type 2 diabetes.
However, a number of doctors are prescribing both drugs to other patients ‘off-label’, or in a way that has not been approved by regulators, causing shortages.
Dr. John Sharretts of the FDA’s Center for Drug Evaluation and Research said: ‘Wegovy is now the first weight loss drug also approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and obesity or overweight.
‘This patient population has a higher risk of cardiovascular disease, heart attacks and strokes.
“Providing a treatment option proven to reduce this cardiovascular risk is a major advance for public health.”
Today’s announcement means it’s more likely that health insurers will cover patients for the drug, which currently costs more than $1,300 per week out of pocket.
Danish drug manufacturer Novo Nordisk published data in November from a study involving 17,604 patients with heart disease. It showed that those who took their drug had a lower risk of heart attacks or strokes.
In the study, patients were randomly assigned to receive a weekly injection of Wegovy or a placebo for 33 months.
During this period, 569 patients who received the drug had a heart attack or stroke, compared to 701 in the placebo group.
Analysis showed this was an overall risk reduction of around 20 percent for the group.
Their risk of heart disease fell by 28 percent, while their risk of non-fatal stroke fell by seven percent and heart-related death by 15 percent.
It was initially thought that weight loss caused by the drug lowered blood pressure and the risk of heart problems.
But the study found that the heart benefits started within six weeks – before any significant weight loss had begun – suggesting that the blood sugar control and reduced inflammation caused by the drug also lowered the risk of cardiovascular events.
Wegovy works by mimicking the hunger hormone glucagon-like peptide-1 (GLP-1), which makes a person feel full even after not eating.
The most common side effects of the drug include nausea, vomiting, diarrhea, constipation, abdominal pain and, in some cases, low blood sugar.
About 18.2 million Americans suffer from heart disease, many of whom are also obese or overweight.
Patients who are overweight or obese are at greater risk for the complication because they are more likely to have high blood pressure or high cholesterol, or because their heart is under increased pressure as it supplies blood and nutrients to the body.