The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication of Novo Nordisk’s semaglutide, marketed as Wegovy, to lower the risk of serious heart problems in overweight or obese adults.
The glycogen-like peptide-1 (GLP-1) receptor agonist was previously sanctioned for obesity treatment and weight management alongside dietary and behavioural changes.
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Semaglutide is the first weight loss medication to prevent cardiovascular incidents such as heart attacks and strokes in individuals with a body mass index of 27 kg/m² or more who have established cardiovascular disease.
The approval is supported by findings from a post-approval clinical study showing that 2.4mg weekly subcutaneous injections of semaglutide for up to five years reduced major adverse cardiovascular event (MACE) occurrences compared to a placebo.
In a multi-national, multicentre, placebo-controlled, double-blind trial involving 17,600 participants, those treated with Wegovy experienced a 20% lower risk of MACE.
Administered via a pre-filled injection pen, semaglutide works by mimicking GLP-1, a hormone that regulates blood sugar.
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By GlobalDataIt binds to pancreatic GLP-1 receptors, boosting insulin secretion post-meals, curbing glucagon release and decelerating gastric emptying to aid in weight loss.
Gastrointestinal issues such as nausea and vomiting are the most common side effects linked to the treatment.
The MHRA will continue to monitor semaglutide’s safety and efficacy.
Individuals experiencing side effects are urged to consult healthcare professionals and report concerns through the MHRA Yellow Card scheme.
MHRA Innovative Medicines deputy director Shirley Hopper stated: “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.”
