CHMP positive for Wegovy (semaglutide 2.4 mg) label in the European Union (EU)

The label update incorporates data showing that Wegovy, when added to standard of care, can reduce heart failure-related symptoms and improve physical limitations and exercise function in people with obesity-related HFpEF, (heart failure with preserved ejection fraction) with or without type 2 diabetes. 

The positive opinion is based on the results from the STEP HFpEF and STEP HFpEF-DM trials conducted in people with obesity-related HFpEF, with or without type 2 diabetes. In both trials, Wegovy demonstrated greater reductions in heart failure-related symptoms and greater improvements in physical limitations, as measured by the patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), alongside greater weight loss compared to placebo. The beneficial effects were consistent regardless of baseline age, sex, race, ethnicity, body mass index (BMI), region, systolic blood pressure, left ventricular ejection fraction, and concomitant heart failure therapy.

The label update also incorporates data which showed that participants receiving Wegovy achieved a greater increase in exercise function, as measured by the difference in 6-minute walking distance (6MWD) from baseline to week 52, compared to those receiving placebo.

“The recommendation to update the EMA label for Wegovy is an important step forward for people with obesity-related HFpEF who currently have limited treatment options. Wegovy improves patients’ health-related quality of life, enabling them to live a life with greater functionality to conduct daily activities. These data further add to the body of evidence for the semaglutide molecule,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.

The recommendation to incorporate the 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.

With the positive opinion from the CHMP, Novo Nordisk expects implementation of the EU label update shortly, following a linguistic review process by the EMA. As communicated earlier this year, Novo Nordisk will resubmit to the FDA for inclusion of data from the STEP HFpEF trials in the Wegovy label in the US in 2025.

About STEP HFpEF and STEP HFpEF-DM trials; The primary objective of STEP HFpEF and STEP HFpEF-DM trials was to investigate the effects of subcutaneous semaglutide 2.4 mg once-weekly on symptoms, physical function, and body weight compared with placebo in patients with obesity-related HFpEF. STEP HFpEF included 529 people with HFpEF (ejection fraction reater than 45%) and obesity (BMI greater than 30 kg/m), while STEP HFpEF-DM included 616 people with HFpEF (ejection fraction greater than 45%), obesity (BMI greater than 30 kg/m) and type 2 diabetes. Both trials had dual primary endpoints: change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to week 52 and change in body weight from baseline to week 52. Key secondary endpoints included change in 6-minute walking distance (6MWD), a hierarchical composite endpoint (all-cause death, heart failure events, changes in KCCQ-CSS and 6MWD from baseline to week 52), and changes in C-reactive protein from baseline (screening) to week 52.