Home Novo Nordisk's Wegovy Gains UK Regulatory Approval for Heart Disease Treatment

Novo Nordisk's Wegovy Gains UK Regulatory Approval for Heart Disease Treatment

Jul 24, 2024 08:45 CST Updated 08:45
Novo Nordisk

Insulin Developer and Manufacturer

Intelligent Finance APP learned that, following the United States, British regulators have also approved the expansion of Novo Nordisk's (NVO.US) weight-loss drug Wegovy to treat heart disease.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has stated that doctors in the UK will be able to prescribe medication aimed at preventing heart attacks or strokes in individuals who already have conditions such as heart disease, obesity, or diabetes. This weight-loss drug has become the first prescription medication in the country intended to prevent cardiovascular events in obese individuals.

In March this year, the U.S. Food and Drug Administration (FDA) also expanded the scope of similar labeling.

Shirley Hopper, MHRA's deputy chief responsible for innovative drugs, said that this decision marks an "important step" in combating the impact of obesity.

Hopper said in a statement: "We are confident that the safety, quality, and efficacy of this drug meet the appropriate regulatory standards."

"She added: 'This treatment option for preventing heart disease and stroke is an important step in addressing the serious health consequences of obesity.'"

Novo Nordisk's重磅产品Wegovy injection has been approved in the UK for the treatment of obesity and weight management, to be used in conjunction with diet, physical activity, and behavioral support.

However, the new approval marks the company's effort to shed Wegovy's image as a "vanity drug" and fend off intensifying competition.

Results from a closely watched late-stage "SELECT" trial published in August 2023 showed that the drug was 20% less effective at reducing major cardiovascular events compared with a placebo.