Novo Nordisk’s Wegovy (semaglutide 2.4 mg), a medication for weight management, is poised for a label update in Europe. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the update, incorporating data highlighting Wegovy’s potential benefits for individuals with obesity-related heart failure with preserved ejection fraction (HFpEF). This condition, affecting a significant portion of heart failure cases, often coexists with obesity and type 2 diabetes.
The label update is driven by the results of the STEP HFpEF and STEP HFpEF-DM trials. These studies showed that Wegovy, when combined with standard care, demonstrated superior reductions in heart failure-related symptoms, improvements in physical limitations, and greater weight loss compared to placebo. Notably, participants receiving Wegovy also exhibited a greater increase in exercise function, measured by the 6-minute walking distance (6MWD), than those receiving placebo.
This label update adds to the recent inclusion of data from the SELECT landmark trial in the Wegovy EMA label. The SELECT trial demonstrated Wegovy’s ability to reduce the risk of heart attack, stroke, and cardiovascular death.
With the CHMP’s positive opinion, Novo Nordisk anticipates the EU label update to be implemented shortly after a linguistic review by the EMA. The company has also communicated its plans to resubmit data from the STEP HFpEF trials to the FDA in 2025 for inclusion in the Wegovy label in the United States.
Novo Nordisk’s commitment to expanding Wegovy’s label to reflect its potential benefits in managing HFpEF underscores the growing recognition of the drug’s diverse therapeutic potential. This positive news comes as Novo Nordisk continues to explore and advance its weight management portfolio, positioning itself as a leader in this evolving field.
