On Tuesday, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved Novo Nordisk’s Wegovy weight loss drug for reducing the risk of severe cardiovascular issues in overweight and obese adults.
This new approval positions Wegovy as the first drug in the U.K. to be prescribed specifically for preventing cardiovascular events related to obesity, highlighting its expanded role in managing health risks beyond just weight loss.
The approval from the MHRA follows a similar expansion of Wegovy’s label by the U.S. Food and Drug Administration (FDA) in March. This regulatory endorsement boosts Wegovy’s status and marks a significant milestone for Novo Nordisk, further validating the drug’s effectiveness in a broader health context.
Following the announcement, Novo Nordisk’s shares saw a modest increase, trading 1.46% higher in the London stock market.
Shirley Hopper, the MHRA’s deputy director of innovative medicines, emphasized the importance of this decision in advancing efforts to combat obesity’s health impacts. She assured that Wegovy met the necessary regulatory standards for safety, quality, and effectiveness, reinforcing its role in preventing heart disease and strokes among those with obesity.
Previously, Wegovy had been approved in the U.K. for obesity treatment and weight management, used in conjunction with diet, exercise, and behavioral support. The new approval not only enhances its therapeutic use but also aims to reshape the perception of Wegovy from merely a “vanity drug” to a critical tool in preventing serious health issues.
The drug’s expanded approval is supported by the results of the SELECT trial, which showed a 20% reduction in major cardiovascular events for Wegovy users compared to a placebo. This trial data underscores Wegovy’s potential to address significant health risks associated with obesity, marking a pivotal development for both Novo Nordisk and the broader fight against obesity-related cardiovascular diseases.