The approval was based on Wegovy's efficacy and safety results from the SELECT cardiovascular outcomes study in which the drug significantly lowered the MACE risk in comparison to placebo
The headquarters of Novo Nordisk in Denmark. (Credit: Novo Nordisk A/S)
Novo Nordisk said that the US Food and Drug Administration (FDA) has expanded the label indication for Wegovy (semaglutide) injection to include the drug’s use to lower the risk of serious heart problems in adults with obesity or overweight.
The approval was based on a supplemental new drug application (sNDA) for the indication of reducing risks of major adverse cardiovascular events (MACE).
These include cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease (CVD).
Wegovy is now indicated in combination with increased physical activity and reduced calorie diet.
The approval was driven by Wegovy’s efficacy and safety results from the multi-centre, placebo-controlled double-blind SELECT cardiovascular outcomes study.
It randomised 17,604 participants to receive either Wegovy or a placebo along with standard-of-care medical treatment and healthy lifestyle counselling.
In the trial, semaglutide statistically significantly lowered the MACE risk by 20% in comparison to placebo when added to the standard of care.
However, the precise mechanism of cardiovascular risk reduction was not established.
The results of SELECT also showed that, over a maximum of five-year duration, MACE risk reductions were attained irrespective of baseline characteristics.
Furthermore, the label is updated to cover data from the study demonstrating a 15% risk reduction in cardiovascular death and a 19% risk reduction in death from any cause, both compared to placebo.
Novo Nordisk executive vice president and development head Martin Holst Lange said: “We are very pleased that Wegovy is now approved in the US as the first therapy to help people manage their weight and reduce cardiovascular risks.
“This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events.”
Novo Nordisk has also submitted a label expansion application in the European Union, and a decision is anticipated by this year.