The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an update to Novo Nordisk’s Wegovy (semaglutide 2.4 mg) label.
This update in the European Union (EU) reflects new data indicating the product’s ability, along with a standard of care, to alleviate symptoms related to heart failure and enhance physical function in individuals with obesity-related heart failure with preserved ejection fraction (HFpEF), irrespective of type 2 diabetes status.
The CHMP's positive opinion is grounded in findings from the STEP HFpEF and STEP HFpEF-DM trials, which involved participants with obesity-related HFpEF.
Wegovy showed significant symptom reduction and physical improvements and greater weight loss compared to a placebo in these trials.
The trials revealed that the benefits of Wegovy were consistent across demographic and clinical subgroups including age, race, sex, body mass index, ethnicity, region, left ventricular ejection fraction, systolic blood pressure and concurrent heart failure therapy.
Wegovy recipients experienced a notable improvement in exercise function, measured by the six-minute walking distance (6MWD) over one year, versus placebo.
This recommendation to include data from the STEP HFpEF trials complements a recent update to the Wegovy EU label, which incorporated results from the SELECT trial demonstrating the asset’s ability to lower heart attack, stroke and cardiovascular death risk.
Novo Nordisk anticipates that the EU label update will take effect soon following the EMA's linguistic review process.
Novo Nordisk Development head and executive vice-president Martin Holst Lange stated: “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.”
The latest development comes after Novo Nordisk signed a $600m deal with NanoVation to develop genetic medicines for rare and cardiometabolic diseases.
