Wegovy® (semaglutide injection) 2.4 mg recommended by NICE to reduce risk of major adverse cardiovascular events, including heart attacks and strokes, in adults with established cardiovascular disease and overweight or obesity (BMI ≥ 27 kg/m2)

NICE has recommended Wegovy^® (semaglutide injection) 2.4 mg as the first GLP-1 RA to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight (BMI ≥ 27 kg/m²).

This comes after the SELECT trial demonstrated that semaglutide 2.4 mg on top of standard of care reduced the risk for first occurrence of MACE by 20 % compared to placebo (hazard ratio, 0.80; 95 % CI, 0.72 to 0.90; p < 0.001) and independent of weight loss. Over the trial period, MACE occurred in 6.5 % of participants receiving semaglutide compared with 8.0 % receiving placebo, representing an absolute risk reduction of 1.5 percentage points.

Overall, the safety profile of semaglutide injection 2.4 mg in SELECT was consistent with previous trial experience in STEP 1. Serious adverse events were lower with those receiving semaglutide compared with placebo (33.4 % vs 36.4 %; p < 0.001). Adverse events leading to treatment discontinuation were more common with semaglutide injection 2.4 mg vs placebo (16.6 % vs 8.2 %; p < 0.001), and were primarily due to gastrointestinal symptoms.

Wegovy^® will be introduced within existing cardiovascular care pathways, enabling clinicians to consider semaglutide as another treatment option alongside standard care for the secondary prevention of cardiovascular events in people with overweight or obesity (BMI ≥ 27 kg/m²). In NICE's assessment it said that in this patient population, "semaglutide provides benefits and value for money, so it can be used routinely across the NHS".

Today's NICE recommendation for Wegovy is an important step forward for people living with established cardiovascular disease and overweight or obesity. It means clinicians in England now have access to a further treatment that NICE has found to be cost effective, the first and only GLP–1 receptor agonist proven to reduce the risk of heart attack, stroke or cardiovascular death in this high–risk population."

Sebnem Avsar Tuna, General Manager, Novo Nordisk UK

Professor Derek Connolly, Consultant Preventative Cardiologist and Vice Chancellor Professorial Fellow in healthcare research at Aston University, Consultant Cardiologist in Birmingham and Council member of the Primary Care Cardiovascular Society said:

"Cardiovascular disease remains one of the leading causes of death in the UK, and people who have already experienced a cardiovascular event continue to face a significant risk of further heart attacks and strokes. The SELECT trial showed that adding semaglutide to current optimal medical therapy reduces major cardiovascular events and was also associated with a reduction in total mortality, independent of weight loss. For clinicians, having another therapy supported by robust outcomes evidence gives us an important additional option to help reduce mortality and the burden of heart attacks and strokes."

Over eight million people in the UK are living with heart and circulatory conditions, and these diseases are responsible for around a quarter of all deaths each year, equivalent to around 170,000 deaths annually. While survival after heart attacks and strokes has improved, an ageing population means that the overall number of people living with cardiovascular disease is forecasted to continue to grow.

Novo Nordisk is exploring ways to best support the NHS to implement NICE's recommendations, with input from NHS clinical experts and organizations.