Novo Nordisk has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion on updating the Wegovy (semaglutide 2.4 mg) label in the European Union (EU). This label modification includes data indicating that Wegovy, when added to standard care, can alleviate heart failure-related symptoms and enhance physical limitations and exercise function in individuals with obesity-associated HFpEF, regardless of whether they have type 2 diabetes.
The favorable opinion is grounded in findings from the STEP HFpEF and STEP HFpEF-DM trials, which demonstrated Wegovy's efficacy compared to a placebo in patients with obesity-related HFpEF.
Novo Nordisk highlighted that Wegovy is the first obesity treatment to gain a positive opinion endorsing a label update that acknowledges its role in reducing symptoms and improving physical limitations and exercise capacity in individuals with obesity-related heart failure with preserved ejection fraction (HFpEF).
Following this positive opinion from the CHMP, Novo Nordisk anticipates the EU label update will be implemented soon, pending a linguistic review process by the EMA.
As previously communicated this year, Novo Nordisk plans to resubmit to the US Food & Drug Administration for the inclusion of data from the STEP HFpEF trials in the Wegovy label in the US by 2025.
