MHRA Sanctions Novo Nordisk’s Wegovy to be Used for Heart Treatment

Wegovy
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Novo Nordisk’s Wegovy, a weight loss medication, for reducing the risk of serious heart problems or strokes in overweight and obese adults. This approval marks the first instance of a GLP-1 obesity drug being prescribed in the UK for the prevention of cardiovascular events in individuals with obesity, following a similar expansion by the U.S. Food and Drug Administration in March. 

Following the announcement, Novo Nordisk’s shares rose, trading 1.46% higher by 4:10 p.m. London time. Shirley Hopper, the MHRA’s deputy director of innovative medicines, hailed the decision as a significant advancement in addressing obesity-related health issues. “We’re assured that the appropriate regulatory standards of safety, quality, and effectiveness for the approval of this medicine have been met,” Hopper stated. She emphasized that the approval of Wegovy as a treatment option to prevent heart disease and strokes represents a crucial step forward in combating the serious health consequences of obesity. 

Previously, Wegovy was approved in the UK for obesity treatment and weight management, to be used in conjunction with diet, physical activity, and behavioral support. The new approval enhances the drug’s profile, moving it beyond its perception as a “vanity drug” and positioning it as a significant medical intervention in the prevention of cardiovascular diseases. 

The approval is backed by the results of the late-stage “SELECT” trial, published in August 2023, which demonstrated the drug’s efficacy in reducing major cardiovascular events by 20% compared with a placebo. This endorsement is a major achievement for Novo Nordisk, solidifying its position in the market amidst growing competition. 

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