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news.The US Food and Drug Administration (FDA) has granted approval for Novo Nordisk's Wegovy (semaglutide 2.4 mg) for lowering cardiovascular risks in adults with established cardiovascular disease (CVD) who are overweight or obese.
This label expansion for Wegovy follows a supplemental New Drug Application (sNDA) submitted by Novo Nordisk. Credit: Novo Nordisk A/S.
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This label expansion follows a supplemental New Drug Application (sNDA) submitted by the company.
As per the latest approval, the treatment is indicated for reducing risks of major adverse cardiovascular events (MACE) including cardiovascular mortality, non-fatal heart attack or myocardial infarction or non-fatal stroke.
The endorsement of Wegovy for the new indication is based on the results from the randomised, double-blind, parallel-group, placebo-controlled SELECT cardiovascular outcomes clinical trial.
The study, which was initiated in 2018, enrolled 17,604 adults across 41 countries to assess the efficacy of semaglutide 2.4mg in comparison to placebo as an adjunct to standard of care for MACE prevention.
Participants in the trial, all of whom were aged 45 years or above with a body mass index (BMI) of 27 kg/m2 or higher and without a history of diabetes, were observed over a five-year period.
The trial’s findings indicated that Wegovy significantly reduced the major adverse cardiovascular event (MACE) risk by 20% when used along with standard care, in comparison to placebo.
Furthermore, the reduction in MACE risk was consistent across various subgroups, including age, sex, race, ethnicity, BMI, and the level of renal function impairment.
Additionally, the updated label for Wegovy includes findings demonstrating a 15% decline in cardiovascular mortality and a 19% reduction in mortality from any cause, both versus placebo.
Novo Nordisk has also sought label expansion for the treatment in the European Union, with a decision anticipated this year.
Novo Nordisk Development head and executive vice-president 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.”
