Wegovy Wins FDA Nod for Heart Risks in Overweight Adults
March 8, 2024The FDA has expanded approval for Novo Nordisk's Wegovy to include reduction of cardiovascular risks in overweight or obese adults with heart disease.
Wegovy's new indication is supported by the SELECT trial, which reported a 20% reduction in major adverse cardiovascular events over three years.
Wegovy, a once-weekly injectable drug, has proven effective in weight loss, with participants losing an average of 9.4% body weight in 2 years.
The drug should be used alongside a reduced calorie diet and increased physical activity.
Novo Nordisk is seeking similar approval in Europe with an EMA decision expected in 2024.
Despite the FDA's approval, Wegovy is currently not available in Portugal.
Novo Nordisk's shares dropped by 2% following the announcement, but there is optimism for future production increases, cost reductions, and broader accessibility.
Summary based on 11 sources
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Sources
Time • Mar 8, 2024
Wegovy Is Good for More Than Just Weight LossNBC News • Mar 8, 2024
FDA approves Wegovy to reduce heart attack and stroke riskQuartz • Mar 8, 2024
Novo Nordisk says its weight loss drug Wegovy is going to China