Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for updating the label of Wegovy (semaglutide 2.4 mg).
According to the Danish pharma company, the update incorporates data from the SELECT cardiovascular outcomes trial. The study demonstrated a reduction in the risk of major adverse cardiovascular events (MACE).
This includes cardiovascular death, non-fatal heart attack (myocardial infarction), and non-fatal stroke. The findings apply to adults with established cardiovascular disease (CVD) who are overweight or obese with initial body mass index (BMI) ≥27kg/m² without diabetes.
The SELECT trial showed that Wegovy significantly reduced the risk of MACE by 20% compared to placebo, in addition to standard care. The trial results indicated consistent risk reductions over up to five years, irrespective of baseline age, sex, race, ethnicity, BMI, and renal function.
While the exact mechanism behind the cardiovascular risk reduction remains unclear, it is considered likely to be multifactorial.
The SELECT trial enroled 17,604 adults and was conducted across 41 countries at over 800 sites. It began in 2018 and concluded in 2023. The trial reported a 15% reduction in cardiovascular death and a 19% reduction in death from any cause.
Additionally, there was an 18% reduction in a heart failure composite endpoint, which includes cardiovascular death, urgent heart failure visits, and hospitalisations for heart failure, compared to placebo.
Novo Nordisk expects the label update to be implemented within approximately one month following the positive opinion from the CHMP.
Novo Nordisk executive vice president and development head Martin Holst Lange said: “We believe that the recommendation to update the EMA label for Wegovy is a significant milestone for people living with cardiovascular disease and obesity.
“The SELECT data demonstrated that in addition to helping people manage their weight, Wegovy has the potential to protect lives by reducing the risks of major adverse cardiovascular events.”
Semaglutide, a GLP-1 receptor agonist, works by mimicking the GLP-1 hormone, which regulates blood sugar levels. The drug binds to GLP-1 receptors on pancreatic cells, enhancing insulin secretion in response to meals, reducing glucagon release, and slowing gastric emptying, which aids in weight loss.
Earlier this week, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved a new indication for the GLP-1 receptor agonist. The approval allows its use to reduce the risk of serious cardiovascular events in adults who are overweight or obese.
