The Food and Drug Administration on Friday approved the popular weight loss drug Wegovy to reduce the risk of heart attack and stroke in adults with cardiovascular disease and obesity or who are overweight.
“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” said John Sharretts, the director of the diabetes and obesity division of the FDA’s Center for Drug Evaluation and Research.
Wegovy made a splash in 2023 after a worldwide independent trial called SELECT demonstrated that the drug significantly reduced the risk of heart attacks and strokes.
Pharmaceutical giant Novo Nordisk, maker of the chemical semaglutide that is the active ingredient in both Ozempic and Wegovy, announced in a press statement that the FDA approval for cardiovascular disease is largely based on the SELECT trial data, which showed that the drug reduced the risk of major adverse cardiovascular events by 20% compared to placebo.
Martin Holst Lange, executive vice president and head of development at Novo Nordisk, said in the press statement that the company is “very pleased” about Friday’s announcement.
“This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy® has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events,” Lange said.
According to the FDA, nearly 70% of adults in the U.S. are medically overweight or obese, conditions that increase the risk of premature death and a multitude of health problems.
A study that was partially funded by Novo Nordisk and published in August estimated that Wegovy could prevent as many as 1.5 million heart attacks in the United States over the next 10 years.
According to the Centers for Disease Control and Prevention, one person dies every 33 seconds in the United States from cardiovascular disease, and someone has a heart attack every 40 seconds.
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Heart disease cost the United States nearly $240 billion each year between 2018 and 2019, including medicine, healthcare services, and loss of productivity due to death.
“FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight,” Sharretts said.