LONDON — The U.K.’s health regulator on Tuesday approved the use of Novo Nordisk‘s Wegovy weight loss drug to reduce the risk of overweight and obese adults suffering from serious heart problems or strokes.
The new approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) makes the Danish pharmaceutical giant’s GLP-1 obesity drug the first in the country to be prescribed for prevention of cardiovascular events in people with obesity.
It follows similar label expansion by the U.S. Food and Drug Administration in March.
Shares of Novo Nordisk were up after the announcement, trading 1.46% higher by 4:10 p.m. London time after pushing higher for much of the session.
The MHRA’s deputy director of innovative medicines, Shirley Hopper, said the decision marked an “important step forward” in combatting the effects of obesity.
“We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this medicine have been met,” Hopper said in a statement.
“This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity,” she added.
Novo Nordisk’s blockbuster Wegovy injection was already approved in the U.K. for treatment of obesity and for weight management, to be used alongside diet, physical activity and behavioral support.
However, the new approval marks a major coup for the company as it seeks to move beyond Wegovy’s image as a “vanity drug” and fend off growing competition.
Results of 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 with a placebo.