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The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for semaglutide (Wegovy; Novo Nordisk) to reduce the cardiovascular risk among overweight and obese adults suffering serious heart problems or strokes.
The glucagon-like peptide-1 receptor agonist (GLP-1 RA) is already approved for use in the treatment of obesity and for weight management.
The approval, announced on 23 July 2024, has made semaglutide 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 BMI higher or equal to 27kg/m2.
The approval is based on data from a post-approval clinical study, published in the New England Journal of Medicine on 11 November 2023, which demonstrated that semaglutide (2.4mg once weekly by subcutaneous injection for up to five years) lowered the incidence of major adverse cardiovascular events compared with placebo.
In the multinational, multicentre, placebo-controlled double-blind trial that randomly assigned more than 17,600 participants to receive either Wegovy or a placebo, Wegovy reduced the risk of major adverse cardiovascular events by 20%.
Events such as cardiovascular death, heart attack and stroke occurred in 6.5% of participants who received Wegovy, compared with 8.0% of those on placebo.
Commenting on the approval, Paul Wright, consultant pharmacist, cardiovascular disease at Barts Health NHS Trust, said: “Whilst there has been significant focus on GLP-1s and their role in obesity, the additional licence is welcomed for those with established cardiovascular disease living with excess weight (BMI>27), as locally this relates to approximately two-thirds of our local post myocardial infarction cohort of patients and globally, cardiovascular disease remains the leading cause of death.
“Historically, in this group of people, reducing cardiovascular risk has been achieved through medications indicated for controlling lipids, hyperglycemia, blood pressure, heart failure and thrombosis. Obesity has been implicated as promoting all these issues, and now evidence has demonstrated with semaglutide that sustained, effective weight loss has an independent cardiovascular benefit even in people without diabetes.
“With the growing armamentarium of options, the role of the pharmacy team will be even more integral in supporting our patients with increasing polypharmacy, such as ongoing adherence and managing potential adverse events.”
The US Food and Drug Administration (FDA) approved Wegovy for the same indication in March 2023 and studies have indicated patients may derive cardiovascular benefit from semaglutide regardless of weight loss.
Pharmacists have previously told The Pharmaceutical Journal that while resources remained scarce, semaglutide would likely be prioritised for individuals most at risk over other indications, namely patients with poorly controlled diabetes.
Before the Labour Party’s general election victory on 4 July 2024, health secretary Wes Streeting said “closer clinical oversight and regulation” of semaglutide prescribing would be a priority if the party won the election.
Commenting on the MHRA approval, Rani Khatib, consultant pharmacist in cardiology and cardiovascular research at Leeds Teaching Hospitals NHS Trust, said: “The data for GLP-1 agonists being of benefit for reducing cardiovascular outcomes and also impacting positively on kidney function [is] growing.”
However, he warned that supply of semaglutide was “a big challenge” that needed addressing “not just nationally but globally”, with off-label use and private prescribing putting “huge pressure on the system”.
“The challenge we have is that, as much as we welcome this, there are two barriers here: one is the shortage, but also the access to the medicines through the tier 3 weight management services, which are struggling.
“They are either not available in certain regions, or they’re hugely overstretched and unable to meet demand,” he said, with waiting lists extending into months and even years in some parts of the country.
“Tackling obesity is of national and global importance, and obesity is one of the major risk factors for cardiovascular disease. The mounting evidence of the benefits of these drugs and access to them due to lack of capacity of tier 3 weight management services and supply are probably begging the need for innovation in the way people are able to access weight management services.”
