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6-K: European Regulatory Authority Adopts a Positive Opinion for an Update of the Wegovy® Label to Reflect Risk Reduction of Major Adverse Cardiovascular Events

SEC ·  Jul 25 23:48
Summary by Futu AI
On July 25, 2024, Novo Nordisk A/S announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed a positive opinion for updating the label of its medication Wegovy (semaglutide 2.4 mg). This update reflects the results from the SELECT cardiovascular outcomes trial, which showed a 20% reduction in major adverse cardiovascular events (MACE) for adults with established cardiovascular disease (CVD) and obesity or overweight without diabetes. The trial, which enrolled 17,604 adults across 41 countries, also indicated reductions in cardiovascular death by 15%, death from any cause by 19%, and an 18% reduction in a heart failure composite endpoint. Despite these findings, the superiority in cardiovascular death and the composite heart failure endpoint were not statistically significant based on the prespecified...Show More
On July 25, 2024, Novo Nordisk A/S announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed a positive opinion for updating the label of its medication Wegovy (semaglutide 2.4 mg). This update reflects the results from the SELECT cardiovascular outcomes trial, which showed a 20% reduction in major adverse cardiovascular events (MACE) for adults with established cardiovascular disease (CVD) and obesity or overweight without diabetes. The trial, which enrolled 17,604 adults across 41 countries, also indicated reductions in cardiovascular death by 15%, death from any cause by 19%, and an 18% reduction in a heart failure composite endpoint. Despite these findings, the superiority in cardiovascular death and the composite heart failure endpoint were not statistically significant based on the prespecified testing hierarchy. Novo Nordisk expects the label update to be implemented within approximately one month following the CHMP's positive opinion. Wegovy is currently indicated for weight management in adults with obesity or overweight in the EU and the US, with additional indications for reducing the risk of MACE in adults with established CVD in the US.

This announcement is a separate document:

Doc 1

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