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EMA’s CHMP Recommends Expanded Wegovy® Label for Obesity-Related HFpEF

Sep 19, 2024

On 19 September 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a label expansion for Novo Nordisk’s Wegovy® (semaglutide 2.4mg) to reflect reduced symptoms and improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection fraction (HFpEF).

The positive opinion was based on positive results of two studies (STEP HFpEF and STEP HFpEF-DM) conducted in people with obesity-related HFpEF, with or without type 2 diabetes.

This follows the CHMP’s positive opinion in July 2024 for an update to the label for Wegovy® to reflect a risk reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either overweight or obesity without diabetes.