(Reuters) – The U.S. FDA has approved Novo Nordisk’s Wegovy for use in lowering the risk of stroke and heart attack in overweight or obese adults who are not diabetic, the Danish drugmaker said on Friday.
Novo’s widely used diabetes drug Ozempic and weight-loss drug Wegovy, both chemically known as semaglutide, belong to a class of drugs called GLP-1 agonists. Originally developed for type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly.
Millions of people already take the drugs, but the FDA’s stamp of approval for the cardiovascular benefits is likely to open their use to more patients.
The Danish drugmaker published the full data in November from a large clinical trial that showed the obesity drug reduced the risk of non-fatal heart attack by 28%, non-fatal stroke by 7% and heart-related death by 15%, compared with a placebo, in patients with pre-existing heart conditions.
In the 17,604-patient trial with a mean duration of 33 months, the difference in heart protective benefits began to appear almost immediately after starting treatment in those who received Wegovy compared with the placebo group, researchers said, suggesting the positive impact was due to more than weight loss.
Novo had at the time said it had filed for an expansion of Wegovy’s approved use in the U.S. and Europe to include heart-disease treatment.
The FDA’s approval of the new cardiovascular indications could give employers and insurers more reason to cover the drug despite its high cost.
Health regulators can expand approved uses of medicines if new data shows them to be effective in other therapeutic areas after initial approval.
The European Union’s drug regulator in late January said it was reviewing whether Wegovy could also be used to reduce the risk of strokes and heart attacks.
U.S.-listed shares of Novo Nordisk were down 2% in afternoon trading.
(Reporting by Sriparna Roy in Bengaluru and Patrick Wingrove in New York; Editing by Bill Berkrot, Pooja Desai and Krishna Chandra Eluri)
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