Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending an update to the Wegovy® (semaglutide 2.4 mg) label in the European Union (EU). This update will include data showing Wegovy®’s ability to reduce heart failure symptoms and improve physical limitations and exercise function in people with obesity-related heart failure with preserved ejection fraction (HFpEF).

Wegovy® is the first obesity medication to receive such a recommendation, marking a significant milestone in obesity and heart failure treatment. The positive opinion is based on findings from the STEP HFpEF and STEP HFpEF-DM clinical trials, which demonstrated that Wegovy® offers effective symptom relief and enhanced physical function compared to placebo for individuals with obesity-related HFpEF, with or without type 2 diabetes.

Clinical Trial Findings
In the STEP HFpEF and STEP HFpEF-DM trials, patients treated with Wegovy® showed 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). Wegovy® also led to greater weight loss and improvements in exercise function, as evidenced by a significant increase in the 6-minute walking distance (6MWD) over 52 weeks compared to placebo.¹ ² These results were consistent across various demographics, including age, sex, race, ethnicity, and body mass index (BMI).

Novo Nordisk’s Executive Commentary
“The recommendation to update the EMA label for Wegovy® represents a major advancement for people with obesity-related HFpEF, who currently face limited treatment options,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. “These data underscore the significant benefits of Wegovy®, allowing patients to regain functionality in their daily lives and improve their overall quality of life.”

Future Updates and Next Steps
This label update also complements the recent inclusion of data from the SELECT trial, which highlighted the cardiovascular benefits of Wegovy®, including reduced risk of heart attack, stroke, and cardiovascular death.³ Novo Nordisk expects the EU label update to be implemented following the EMA’s linguistic review process.

Looking ahead, Novo Nordisk plans to resubmit its request to the US Food & Drug Administration (FDA) for the inclusion of STEP HFpEF data in the US Wegovy® label in 2025.