The Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for semaglutide (Wegovy) to reduce the risk of overweight and obese adults suffering serious heart problems or strokes.
This medicine, a GLP-1 receptor agonist, was already approved for use in the treatment of obesity and weight management, as well as in diet, physical activity, and behavioural support. The approval means that semaglutide is the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart attack and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2.
The approval is based on new data from a post-approval clinical study which demonstrated that semaglutide (2.4 mg once weekly by subcutaneous injection, for up to five years) lowers the incidence of major adverse cardiovascular events (MACE) vs placebo.
In a multi-national, multi-centre, placebo-controlled double-blind trial that randomly assigned over 17,600 participants to receive either Wegovy or a placebo, Wegovy significantly reduced the risk of major adverse cardiovascular events by 20 per cent, such as cardiovascular death, heart attack and stroke, which occurred in 6.5 per cent of participants who received Wegovy compared to 8 per cent of participants who received placebo.
Shirley Hopper, Deputy Director of Innovative Medicines, MHRA 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.”
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