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Danish multinational pharmaceutical company Novo Nordisk has announced that the European Medicines Agency (EMA) has recommended a Wegovy label update to reflect reduced symptoms related to heart failure and an improvement in physical functions.

Wegovy, whose active pharmaceutical ingredient is semaglutide, is a glucagon-like peptide 1 receptor agonist, used to manage obesity, improve glycemic control in type 2 diabetes mellitus, and lower the risk of serious adverse cardiovascular events in certain adult patients.

The drug acts by inducing insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion

Wegovy’s label update is anchored on data from two clinical trials dabbed STEP HFpEF and STEP HFpEF-DM that showed use of Wegovy resulted in a decrease in heart failure-related symptoms and an improvement in physical limitations, as assessed by the patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).

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“Wegovy improves patients' health-related quality of life, enabling them to live a life with greater functionality to conduct daily activities.”

 

Martin Holst Lange, Executive Vice President, Novo Nordisk.

The trials included a total of 1145 participants with heart failure and preserved ejection fractions of 45% and above who are clinically obese. Some participants had type 2 diabetes; others did not.

Novo Nordisk anticipates that Wegovy’s EU label update will be implemented soon after the EMA completes its linguistic evaluation procedure.

 Currently, the drug is recommended as a supplement to a lower-calorie diet and more exercise for individuals who are either overweight or obese and who also have at least one weight-related comorbid disease.

 The company is also planning to reapply to the US Food & Drug Administration in 2025 to incorporate results from these trials into the Wegovy® label in the US.

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