HQ Team
July 26, 2024: The European Medicines Agency has backed Novo Nordisk’s Wegovy to expand the weight-loss drug’s application to lower heart risks and strokes in non-diabetic adults with obesity, according to a statement from the EU regulator.
The regulator finalised “its assessment of an application to extend the indication of the medicine Wegovy to include prevention of major cardiovascular (heart and blood circulation) problems (non-fatal heart attack, stroke or death from heart and circulation problems) in adults with established cardiovascular disease and a BMI (body mass index) of at least 27 kg/m2.”
The agency “did not agree on granting a separate indication for prevention, but the medicine’s product information will be updated to include the study results submitted for the application so that healthcare professionals have access to up-to-date data on the effects of Wegovy in people with established cardiovascular disease and a BMI of 27 kg/m2 or greater.”
The UK’s Medicines and Healthcare products Regulatory Agency on June 24 approved Novo Nordisk’s weight-loss drug to cut the risk of obesity and adults suffering from heart problems or stroke.
FDA approval
Semaglutide, branded as Wegovy, is a GLP-1 receptor agonist that was already approved for use in the treatment of obesity and for weight management, to be used alongside diet, physical activity and behavioural support.
In March the US Food and Drug Administration approved the drug for treating the same conditions.
That approval was based on new data from a post-approval clinical study which demonstrated that semaglutide (2.4 mg once weekly by subcutaneous injection, for up to five years) lowers the incidence of major adverse cardiovascular events when compared to placebo.
A trial randomly assigned more than 17,600 participants to receive either Wegovy or a placebo. The trial was conducted in 41 countries at more than 800 investigator sites and was initiated in 2018 and completed in 2023.
Wegovy reduced the risk of major adverse cardiovascular events by 20%, such as cardiovascular death, heart attack and stroke, which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received a placebo.
Earlier this year, the USFDA approved the drug for the prevention of cardiovascular events in people with obesity.
‘Significant milestone’
Novo Nordisk stated the Committee for Medicinal Products for Human Use had adopted “a positive opinion” for an update of the Wegovy label to reflect data from the trial.
The trial demonstrated that risk reductions from major adverse cardiovascular events were achieved for up to five years, regardless of age, sex, race or ethnicity.
“We believe that the recommendation to update the EMA label for Wegovy is a significant milestone for people living with cardiovascular disease and obesity,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
“The trial 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.”
The label update also includes data from the 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 placebo..
Novo Nordisk expects to implement the label update within approximately a month.
