Novo Nordisk announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended an update to the label of Wegovy® (semaglutide 2.4 mg) to reflect its ability to reduce symptoms of heart failure and improve physical function in individuals with obesity-related heart failure with preserved ejection fraction (HFpEF). This recommendation is based on positive results from the STEP HFpEF and STEP HFpEF-DM clinical trials, which demonstrated significant improvements in heart failure symptoms, physical limitations, exercise function, and weight loss in patients, both with and without type 2 diabetes. With this update, Wegovy® becomes the first obesity medication to receive a positive opinion for addressing HFpEF symptoms, marking a significant advancement in obesity-related heart failure treatment.

Despite these positive developments in Europe, Novo Nordisk has withdrawn its FDA application for an expanded label on Wegovy® in the United States, aimed at treating heart failure with preserved ejection fraction (HFpEF). This decision followed discussions with the FDA, but the company plans to resubmit the application early next year. The withdrawal does not affect Wegovy®'s current approval for obesity treatment, and Novo Nordisk remains optimistic about future approval for this expanded use in the U.S., supported by positive clinical data.

For more information, visit BioSpace (EU label update) or Fierce Pharma (FDA application withdrawal).