'This patient population has a higher risk of cardiovascular death, heart attack and stroke,' FDA official says
The FDA on Friday said it approved Novo Nordisk's popular weight-loss drug Wegovy to reduce the risk of severe heart issues in overweight or obese adults.
The agency's announcement broadens the use of Wegovy, an injectable medication, to reduce the riks of cardiovascular death, heart attack or stroke in adults who have cardiovascular disease and who are obese or 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," John Sharretts, a director within the FDA's Center for Drug Evaluation and Research, said in a statement.
"This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health," he said.
Shares of Novo Nordisk (NVO) were down 1.6% after hours on Friday.
Novo Nordisk said that the approval was based on a trial that found that Wegovy "statistically significantly reduced the risk" of major adverse cardiovascular events by 20% compared with a placebo. The company said the "exact mechanism of cardiovascular risk reduction has not been established."
The company also said it had filed for a label expansion in the European Union, with a decision is expected this year.
Martin Holst Lange, head of development at Novo Nordisk, said that the 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."
The FDA said that Wegovy should be used alongside a lower-calorie diet and more exercise.
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