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Novo Nordisk A/S: Wegovy recommended by European regulators to amend label to reduce symptoms of heart failure and improve physical function Page 1

Novo Nordisk A/S: Wegovy recommended by European regulators to amend label to reduce symptoms of heart failure and improve physical function Page 1

Wegov recommended by European regulators for a label update to reduce symptoms of heart failure and improve physical function

  • Wegovy (semaglutide 2.4 mg) is the first anti-obesity drug to receive a positive label change recommendation reflecting reduced symptoms and improved physical disability and motor function in people with obesity-related heart failure with preserved ejection fraction (HFpEF).
  • The positive assessment is based on the results of the STEP HFpEF and STEP HFpEF-DM studies, which showed that Wegovy is an effective therapy compared with placebo for people with obesity-related HFpEF.1,2

Bagsværd, Denmark, September 19, 2024 – Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for a label update for Wegovy (semaglutide 2.4 mg) in the European Union (EU). The label update includes data demonstrating that Wegovy, when added to standard of care, can reduce heart failure-related symptoms and improve disability and movement function in people with obesity-related HFpEF, with or without type 2 diabetes.1,2

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