The European Medicines Agency (EMA) has endorsed Novo Nordisk's Wegovy (semaglutide 2.4 mg) for the treatment of heart failure in obese patients. This decision marks the second endorsement for Wegovy beyond its established use for weight loss, strengthening the argument for its multiple health benefits.
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a label update in the European Union (EU) to incorporate data demonstrating Wegovy's ability to reduce heart failure-related symptoms and improve physical limitations and exercise function in individuals with obesity-related heart failure with preserved ejection fraction (HFpEF), irrespective of type 2 diabetes status.
Clinical Trial Data
The positive opinion is based on results from the STEP HFpEF and STEP HFpEF-DM trials. These trials showed that Wegovy, when added to standard care, led to greater reductions in heart failure-related symptoms and improvements in physical limitations, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), compared to placebo. Participants receiving Wegovy also experienced a greater increase in exercise function, assessed by the 6-minute walking distance (6MWD) test.
Martin Holst Lange, Executive Vice President and Head of Development at Novo Nordisk, stated that the label update is an important step forward for people with obesity-related HFpEF who currently have limited treatment options. He emphasized that Wegovy improves patients' health-related quality of life, enabling them to live a life with greater functionality to conduct daily activities.
Implications and Future Plans
The recommendation to incorporate data from the STEP HFpEF trials adds to the recent Wegovy EMA label update that included data from the SELECT landmark trial to reflect risk reduction of heart attack, stroke, and cardiovascular death. Novo Nordisk anticipates the EU label update will be implemented shortly, following a linguistic review process by the EMA.
Novo Nordisk plans to resubmit data to the U.S. Food & Drug Administration (FDA) in 2025 for inclusion of data from the STEP HFpEF trials in the Wegovy label in the US.
About Heart Failure with Preserved Ejection Fraction (HFpEF)
Heart failure affects at least 64 million people worldwide and is especially prevalent in those with obesity and/or type 2 diabetes. HFpEF is the most common form of heart failure, comprising approximately 50% of all heart failure cases. Obesity is considered a key driver in the development and progression of HFpEF, with approximately 80% of people with HFpEF living with overweight or obesity.
