Novo Nordisk said 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.
Wegovy has been authorised by the European Union for obesity treatment since 2022.
The label update includes data that showed that the drug can help reduce heart failure-related symptoms. It also improves physical limitations and exercise function.
This benefit applies to people with obesity-related HFpEF, whether they have type 2 diabetes or not.
The positive opinion for Wegovy is based on results from the STEP HFpEF and STEP HFpEF-DM trials.
In both trials, semaglutide led to greater reductions in heart failure-related symptoms.
It also improved physical limitations, as shown by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).
Additionally, participants on semaglutide experienced more significant weight loss compared to those on placebo.
The label update highlights that Wegovy also improved exercise function.
Participants showed a greater increase in six-minute walking distance (6MWD) from baseline to week 52, compared to those receiving a placebo. These benefits were consistent across various demographics.
Novo Nordisk development head and executive vice president Martin Lange said: “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 recommendation to include data from the STEP HFpEF trials builds on the recent Wegovy EMA label update. It was based on CHMP’s positive opinion in July.
This update already incorporated findings from the SELECT landmark trial, which demonstrated risk reduction for heart attack, stroke, and cardiovascular death.
With the CHMP’s positive opinion, Novo Nordisk anticipates the implementation of the EU label update soon, pending a linguistic review by the EMA.
Additionally, the Danish healthcare company plans to resubmit data from the STEP HFpEF trials to the US Food & Drug Administration (FDA) for inclusion in the Wegovy label in 2025.
