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MHRA approves stroke prevention indication for Wegovy

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MHRA approves stroke prevention indication for Wegovy

Semaglutide has become the first weight loss drug to be approved by the MHRA to prevent cardiovascular events such as heart attack and stroke.  

Already approved for the treatment of obesity and weight management, semaglutide may now be prescribed to prevent cardiovascular events such as cardiovascular death, non-fatal heart attack and non-fatal stroke in patients with diagnosed cardiovascular disease and a BMI of 27kg/m2 or higher. 

The GLP-1 receptor agonist, marketed in the UK as Wegovy, was given the new indication after a new clinical study found that once-weekly injection with 2.4mg reduced the incidence of major cardiovascular events (MACE) by 20 per cent. 

The multi-national double blind trial saw 17,600 participants prescribed either Wegovy or a placebo. The rate of MACEs was 6.5 per cent in the Wegovy group and 8 per cent in the placebo group. 

The MHRA’s Shirley Hopper said: “Our key priority is enabling access to high quality, safe and effective medical products.  

“We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this medicine have been met. This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity. 

“As with all medicines, we will keep its safety under close review.” 

Professor Bryan Williams, chief scientific and medical officer at the British Heart Foundation, said: “It is important that people using the drug to lose weight and improve their health are given the support they need from healthcare professionals to maintain these improvements long into the future. 

“This means appropriate training and healthcare workforce development, along with policies to create a wider environment that supports everyone to stay as healthy as possible. 

“Altogether, this can help save lives from the devastating impact of heart attacks and strokes.”

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