03:52 PM EST, 03/08/2024 (MT Newswires) -- Novo Nordisk ( NVO ) said Friday the US Food and Drug Administration approved the Danish drugmaker's weight loss drug for cardiovascular risk reduction.

The FDA approved the Wegovy injection for reducing risks of "major adverse cardiovascular events," including heart attack and stroke in adults with overweight or obesity, according to the company.

Obesity and overweight increase the risk of premature death and a variety of health problems, including heart attack and stroke, the FDA said in a statement.

The approval follows trial data that showed Wegovy "significantly" reducing the risk of major adverse cardiovascular events by 20% compared to placebo, Novo Nordisk ( NVO ) said. However, "the exact mechanism of cardiovascular risk reduction has not been established," it added.

"We are very pleased that Wegovy is now approved in the US as the first therapy to help people manage their weight and reduce cardiovascular risks," Martin Holst Lange, head of development at Novo Nordisk ( NVO ), said in a statement.

Novo Nordisk ( NVO ) said it has filed for a label expansion in the European Union, with a decision expected in 2024.

Patients with cardiovascular disease and obesity or overweight have "a higher risk of cardiovascular death, heart attack and stroke," the FDA said. "Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."

Novo Nordisk's ( NVO ) New York Stock Exchange-listed shares were falling 2% in Friday afternoon trade, trimming the year-to-date gain to nearly 29%.

Price: 133.23, Change: -2.69, Percent Change: -1.98