Novo Nordisk's Wegovy weight loss drug has experienced a meteoric rise in popularity.
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LONDON — The U.K. health regulator on Tuesday approved the use of New NordiskThe weight-loss drug Wegovy reduces the risk of serious heart problems or stroke in overweight and obese adults.
The new approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) makes the Danish pharmaceutical giant's anti-obesity drug GLP-1 the first in the country to be prescribed for the prevention of cardiovascular events in people with obesity.
This follows a similar label expansion by the U.S. Food and Drug Administration in March.
Novo Nordisk shares rose after the announcement, trading 1.46% higher at 4:10 p.m. London time, after advancing for much of the session.
MHRA deputy director for innovative medicines Shirley Hopper said the decision marked a “significant step forward” in the fight against the effects of obesity.
“We are confident that the appropriate regulatory standards for safety, quality and efficacy have been met for the approval of this medicine,” Hopper said in a statement.
“This treatment option that prevents heart disease and stroke is an important step forward in addressing the serious health consequences of obesity,” he added.
Novo Nordisk's blockbuster Wegovy injection has already been approved in the UK for the treatment of obesity and weight management, to be used alongside diet, physical activity and behavioural support.
The new approval is, however, a major coup for the company, which is seeking to move beyond Wegovy's image as a “vanity drug” and fend off growing competition.
Results from a closely watched late-stage “SELECT” trial, published in August 2023, pointed to the drug's efficacy in reducing major cardiovascular events by 20% compared to placebo.