Novo Nordisk has announced that the European Medicines Agency’s (EMA) human medicines committee recommended that Wegovy’s (semaglutide 2.4mg) label be updated to reflect the risk reduction of major adverse cardiovascular events.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the glucagon-like peptide-1 receptor agonist’s label should include outcomes from the SELECT cardiovascular outcomes trial of more than 17,600 patients aged 45 years and older with established cardiovascular disease (CVD) and a body-mass index (BMI) of at least 27.
Results showed Wegovy reduced the risk of major adverse cardiovascular events (MACE), including cardiovascular death and non-fatal heart attacks, by 20% compared to placebo when added to the standard of care.
The study also showed risk reductions in MACE were achieved regardless of baseline age, sex, race, ethnicity, BMI and level of renal function impairment over a period of up to five years.
Obesity is associated with serious complications, including type 2 diabetes, chronic kidney disease and an increased risk of CVD.
Taken as a solution for injection in a pre-filled pen, Wegovy is already authorised in the EU alongside a reduced-calorie diet and increased physical activity for weight management in certain individuals.
Commenting on the latest backing, Martin Holst Lange, executive vice president and head of development at Novo Nordisk, said: “We believe that the recommendation to update the EMA label for Wegovy is a significant milestone for people living with CVD 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 MACE.”
Novo said it expects the label update to be implemented within approximately one month following the positive opinion.
Beyond weight management, semaglutide has also been authorised in the EU to treat type 2 diabetes under the brand name Ozempic.
Research conducted by a team from the University of Oxford recently showed that diabetes patients receiving semaglutide experienced a lower risk of cognitive problems.
The observational study used records from more than 100 million patients in the US, including over 20,000 who were taking semaglutide, and found that the drug was not associated with an increased risk of neurological and psychiatric conditions, such as dementia, depression or anxiety, compared to other common anti-diabetic medications, challenging recent safety concerns.