WASHINGTON (dpa-AFX) - Novo Nordisk said that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy (semaglutide 2.4 mg) label in the European Union (EU). The label update incorporates data showing that Wegovy, when added to standard of care, can reduce heart failure-related symptoms and improve physical limitations and exercise function in people with obesity-related HFpEF, with or without type 2 diabetes.
The positive opinion is based on results from the STEP HFpEF and STEP HFpEF-DM trials, which showed that Wegovy is an effective therapy compared to placebo for people with obesity-related HFpEF.
The company noted that Wegovy is the first obesity medication to receive a positive opinion recommending a label update that reflects reduced symptoms and improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection fraction (HFpEF).
With the positive opinion from the CHMP, Novo Nordisk expects implementation of the EU label update shortly, following a linguistic review process by the EMA.
As communicated earlier this year, Novo Nordisk will resubmit to the US Food & Drug Administration for inclusion of data from the STEP HFpEF trials in the Wegovy label in the US in 2025.
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