EU regulators recommend Wegovy label update for obesity-related heart failure
A European regulatory committee recommended updating Wegovy's label to include reduced heart failure symptoms in obesity-related HFpEF; the U.S. label is unchanged for now.
On September 19, 2024, Novo Nordisk said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion to update the European Union label for Wegovy (semaglutide 2.4 mg) to reflect reduced heart failure symptoms and improved physical function in people with obesity-related heart failure with preserved ejection fraction, or HFpEF [1].
The company said Wegovy is the first obesity medicine to receive a positive opinion recommending a label update for that use in Europe [1]. A CHMP positive opinion is a recommendation, not the final label change. Novo Nordisk said it expects the EU label update to be implemented shortly, after a linguistic review by the EMA [1].
The opinion rests on two trials, STEP HFpEF and STEP HFpEF-DM [1]. STEP HFpEF enrolled 529 people with HFpEF (ejection fraction of at least 45%) and obesity (BMI of at least 30) [1]. STEP HFpEF-DM enrolled 616 people with HFpEF, obesity and type 2 diabetes [1]. Both trials tested weekly subcutaneous semaglutide 2.4 mg against placebo [1].
In both trials, people taking Wegovy had greater reductions in heart failure-related symptoms and greater improvements in physical limitations, measured with the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), along with greater weight loss than those taking placebo [1]. The announcement did not include the specific point differences on that questionnaire or the specific weight changes. Participants taking Wegovy also had a greater increase in exercise function from the start of the trial to week 52, measured by six-minute walking distance, compared with placebo [1].
Novo Nordisk said the effects were consistent regardless of age, sex, race, ethnicity, BMI, region, systolic blood pressure, left ventricular ejection fraction and other heart failure therapy at the start of the trials [1]. Each trial had two primary goals: change in KCCQ-CSS score and change in body weight from the start to week 52. Other measured outcomes included six-minute walking distance, a combined measure of all-cause death, heart failure events and changes in scores and walking distance, and changes in C-reactive protein [1].
"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," said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk [1].
The recommendation adds to a recent EU Wegovy label update that included data from the SELECT trial on reducing the risk of heart attack, stroke and cardiovascular death [1]. In the EU, Wegovy is already indicated for weight management alongside a reduced-calorie diet and increased physical activity in adults with a BMI of 30 or higher, or 27 or higher with at least one weight-related condition, and for some children aged 12 and older [1].
Why it matters for patients
HFpEF is the most common form of heart failure, accounting for about 50% of all heart failure cases, and roughly 80% of people with HFpEF have overweight or obesity, according to the company [1]. Symptoms include shortness of breath, swollen legs and feet, and trouble exercising, which can reduce quality of life [1].
For people in the United States, nothing changes yet. Wegovy's U.S. label has not been updated to include the STEP HFpEF results, and Novo Nordisk said it will resubmit to the FDA in 2025 [1]. Whether the FDA will grant a similar label update has not been disclosed. The European recommendation covers the Wegovy label for semaglutide 2.4 mg [1]; the announcement did not mention other semaglutide products or the tirzepatide medicines Mounjaro and Zepbound.
How much symptom scores or walking distance improved on average is not included in the announcement, so the size of the benefit for an individual patient has not been reported there [1].
What happens next
Novo Nordisk expects the EU label update to take effect shortly after the EMA's linguistic review [1]. The company says it will resubmit the STEP HFpEF data to the FDA for the U.S. Wegovy label in 2025 [1].
Sources
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