EU Regulator Set to Decide on Wegovy’s Heart Benefits in April
- Novo Nordisk is seeking a label change for obesity shot Wegovy
- EMA to meet with Novo, FDA in March to discuss supply issues
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The European Medicines Agency expects to decide in April whether Novo Nordisk A/S’s weight-loss drug Wegovy can also be used to treat heart patients with obesity, said Executive Director Emer Cooke.
The drugmaker is seeking approval in both Europe and the US for a label change that would allow Wegovy to be prescribed as a therapy to reduce heart attacks and strokes in people who are overweight. The US Food and Drug Administration has granted priority review for Novo’s request.