Bagsværd, Denmark, 25 July 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with established cardiovascular disease (CVD) and either overweight or obesity (initial BMI ≥27 kg/m2) without diabetes.
The SELECT trial demonstrated that Wegovy® statistically significantly reduced the risk of MACE by 20% compared to placebo when added to standard of care. In addition, the findings from SELECT showed that over a period of up to five years, risk reductions in MACE were achieved regardless of baseline age, sex, race, ethnicity, body mass index (BMI) and level of renal function impairment. The exact mechanism of cardiovascular risk reduction has not been established but is likely multifactorial.
“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”, said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
The label update also includes data from the SELECT trial showing a risk reduction in cardiovascular death by 15%, a risk reduction of death from any cause by 19%, and an 18% risk reduction in a heart failure composite endpoint, comprised of cardiovascular death, urgent heart failure visits and hospitalisations for heart failure, all compared to placebo1.
Following the positive opinion from the CHMP, Novo Nordisk expects implementation
