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Overweight and obese adults with heart disease could now get a prescription for Wegovy to reduce their risk of having a heart attack or stroke.
The FDA today approved the treatment for this use in non-diabetic adults after large-scale studies showed the drug reduced the risk of complications by up to 28 percent.
The agency added that Wegovy, which uses semaglutide, should be used in conjunction with a low-calorie diet and increased levels of physical activity.
Shares in the drug’s owner, Novo Nordisk, rose to $566 billion yesterday, making it the world’s 12th most valuable company, after it unveiled a new drug that could cause weight loss twice as fast as Ozempic.
The FDA today approved the drug for this use in non-diabetic patients, after clinical trials showed it reduced the risk by up to 28 percent.
Wegovy, which uses the drug semaglutide, has already been 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, several doctors are prescribing both drugs to other patients “off-label,” or in a way that is not 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 is at increased risk of cardiovascular death, heart attack and stroke.
“Offering a treatment option that has been shown to reduce this cardiovascular risk is an important advance for public health.”
Today’s announcement means health insurance companies are more likely to cover the drug for patients, which can cost more than $1,300 a week out-of-pocket.
Danish drugmaker Novo Nordisk released data from a trial involving 17,604 heart disease patients in November that showed those who took its drug had a lower risk of heart attacks or strokes.
In the trial, 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 with 701 who were in the placebo group.
The analysis showed that this was an overall risk reduction of about 20 percent for the group.
Their risk of heart disease was reduced by 28 percent, while their risk of non-fatal stroke was reduced by seven percent and that of heart-related death by 15 percent.
About 18.2 million Americans have heart disease, and a large proportion of them are obese or overweight.
Patients in this category are at higher risk for complications, doctors say, because they are more likely to have high blood pressure or high cholesterol or because their heart is under greater pressure as it supplies blood and nutrients to the body.