Novo Nordisk, a global pharmaceutical company, has gained a positive opinion from the European Medicines Agency’s (EMA) committee for the use of Wegovy to reduce the risk of major adverse cardiovascular events.
This is applicable to adults with established cardiovascular disease and those who are overweight or obese (classified at BMI ≥27 kg/m2) who do not have diabetes.
The opinion came off the back of the SELECT cardiovascular outcomes trial, which demonstrated that the administration of Wegovy could reduce the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adult participants.
Reduced risk of MACE through Wegovy administration
The SELECT trial demonstrated that Wegovy could reduce the risk of major adverse cardiovascular events (MACE) by 20% compare to placebo when used as an adjuvant to standard of care protocols.
There was also a risk reduction in MACE regardless of baseline age, sex, race, ethnicity, BMI and level of renal function impairment during the five year study period.
“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 will include data from the trial depicting a risk reduction in cardiovascular death by 15% and a 18% risk reduction in heart failure.
Novo Nordisk expects the implementation of the label update within one month following the positive opinion from the EMA.