UK approves Novo Nordisk’s Wegovy for cardiovascular event prevention in obese adults

UK —The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted approval for the use of Novo Nordisk’s Wegovy (semaglutide) weight loss drug.

This approval marks a significant step in reducing the risk of severe heart problems or strokes in overweight and obese adults.

With this new endorsement, Wegovy becomes the first obesity drug in the UK prescribed specifically for preventing cardiovascular events in obese individuals.

This decision follows a similar label expansion by the U.S. Food and Drug Administration in March.

The MHRA highlighted that this approval is based on compelling new data from a post-approval clinical study.

The study demonstrated that semaglutide, a key component of Wegovy, significantly lowers the incidence of major adverse cardiovascular events (MACE) compared to a placebo.

Commenting on this landmark decision, Shirley Hopper, MHRA Deputy Director of Innovative Medicines, emphasized the agency’s commitment to enabling access to high-quality, safe, and effective medical products.

She assured the public that the approval process met all the necessary regulatory standards of safety, quality, and effectiveness.

Hopper also noted that this treatment option, which prevents heart disease and strokes, represents a crucial step forward in tackling the serious health consequences of obesity.

Further supporting this decision, Professor Bryan Williams, Chief Scientific and Medical Officer at the British Heart Foundation pointed out that nearly two-thirds of adults in England are living with excess weight or obesity.

He underscored that several recent studies have shown semaglutide to be an effective tool in improving the quality of life for those with cardiovascular disease.

Specifically, it has lowered the risk of serious cardiac events. Professor Williams also stressed the importance of providing ongoing support from healthcare professionals to individuals using the drug to ensure they maintain these health improvements over the long term.

Wegovy is administered as a solution for injection via a pre-filled pen, with semaglutide as the active ingredient.  This   GLP-1 receptor agonist mimics the action of the GLP-1 hormone, which regulates blood sugar levels.

By binding to GLP-1 receptors on pancreatic cells, semaglutide enhances insulin secretion in response to meals, reduces glucagon release, and slows the gastric emptying process. These actions collectively contribute to weight loss.

Despite its benefits, the most common side effects of Wegovy are gastrointestinal disorders, including nausea, diarrhea, constipation, and vomiting.

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