EU regulators recommend a Wegovy label update for obesity-related HFpEF

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on September 19, 2024, recommending an update to the Wegovy label in the European Union. The update would note that semaglutide 2.4 mg, when added to standard care, can reduce heart failure symptoms and improve physical function in people with obesity-related heart failure with preserved ejection fraction (HFpEF) ^[1]. Novo Nordisk said this makes Wegovy the first obesity medicine to get this kind of recommendation in Europe ^[1].

The opinion rests on two trials: STEP HFpEF and STEP HFpEF-DM. STEP HFpEF enrolled 529 people with HFpEF (ejection fraction of 45% or higher) and obesity (BMI of 30 or higher), while STEP HFpEF-DM enrolled 616 people with the same heart condition, obesity, and type 2 diabetes ^[1]. Both trials tracked the same two main outcomes: change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), which measures heart failure symptoms and quality of life, and change in body weight, both measured at 52 weeks ^[1]. In both studies, people taking semaglutide showed greater improvement in KCCQ-CSS scores and lost more weight than those on placebo ^[1].

The trials also measured how far participants could walk in six minutes, a common test of exercise capacity. People on semaglutide showed a bigger increase in walking distance from baseline to week 52 compared to placebo ^[1]. Novo Nordisk said these benefits held up across different ages, sexes, races, ethnicities, body mass indexes, regions, blood pressure levels, and heart pumping ability, and regardless of what other heart failure medicines people were already taking ^[1].

HFpEF is now the most common form of heart failure, making up about half of all heart failure cases, according to Novo Nordisk's release citing outside research ^[1]. Heart failure overall affects at least 64 million people worldwide, and it's especially common in people with obesity or type 2 diabetes ^[1]. Roughly 80% of people with HFpEF live with overweight or obesity, a condition linked to shortness of breath, swollen legs and feet, and trouble exercising ^[1]. Martin Holst Lange, an executive vice president at Novo Nordisk, said the CHMP recommendation is "an important step forward for people with obesity-related HFpEF who currently have limited treatment options" ^[1].

Why it matters for patients

This is a European regulatory action, not a US one. The label change applies to Wegovy as sold under EU rules, and it has not yet reached the US label ^[1]. For American patients, the practical relevance right now is limited to what the trial results themselves show: that in two clinical trials, people with obesity-related HFpEF who took semaglutide reported fewer heart failure symptoms and could walk farther after a year, compared with people on placebo ^[1]. Whether and when that gets reflected on the US Wegovy label is a separate, pending question.

People with HFpEF who are also managing obesity may want to know that this is an active area of study, since current treatment options for this specific heart condition remain limited ^[1]. But the label update itself is a European regulatory step, and it does not by itself change what US prescribers can put on a prescription pad today.

What happens next

Novo Nordisk said it expects the EU label update to take effect soon, after the EMA completes a routine linguistic review ^[1]. Separately, the company said it plans to resubmit its application to the US Food and Drug Administration in 2025, seeking to add the STEP HFpEF trial data to the Wegovy label in the United States ^[1]. No date has been given for when the FDA might decide on that request.