Novo Nordisk’s semaglutide has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to reduce the risk of serious heart problems or stroke in overweight and obese adults.
The glucagon-like peptide-1 receptor agonist, marketed under the brand name Wegovy, is now the first weight loss drug to be prescribed to prevent cardiovascular events in patients with established cardiovascular disease (CVD) and a body-mass index (BMI) of at least 27.
Approximately 7.6 million people are living with heart and circulatory diseases in the UK, while nearly two-thirds of adults in England are living with excess weight or obesity, which increases CVD risk.
Taken as a solution for injection in a pre-filled pen, semaglutide is already authorised for use alongside diet, physical activity and behavioural support for weight management.
The MHRA’s latest decision on the drug was supported by data from a post-approval clinical study of more than 17,600 patients aged 45 years and older with pre-existing CVD and a BMI of 27 or higher.
Results showed that semaglutide significantly reduced the risk of major adverse cardiovascular events by 20%, including heart attack and stroke, compared to placebo.
Shirley Hopper, MHRA deputy director of innovative medicines, said: “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.”
Semaglutide has also been authorised by the MHRA to treat type 2 diabetes under the brand name Ozempic.
The approval comes less than two weeks after new research conducted by a team from the University of Oxford showed that diabetes patients receiving semaglutide experienced a lower risk of cognitive problems.
The observational study, published in The Lancet’s eClinicalMedicine journal, used records from more than 100 million patients in the US, including over 20,000 who were taking semaglutide.
It found that the drug was not associated with an increased risk of neurological and psychiatric conditions, such as dementia, depression or anxiety, compared to other common anti-diabetic medications, challenging recent safety concerns.