EU regulator backs use of Novo's Wegovy for obesity-related heart condition
Adds background on Wegovy and trial details in paragraphs 3,4, 5 and 6, Lilly's drug details in paragraph 9
Sept 19 (Reuters) -The European Medicines Agency backed the use of Novo Nordisk's NOVOb.CO popular drug Wegovy to help ease heart failure in people with obesity, the Danish drugmaker said on Thursday.
This marks the regulator's second backing for a use of Wegovy beyond weight loss and further strengthens Novo's case that the medicine has multiple health benefits.
The agency has also backed use of Wegovy to lower major heart risks and strokes in overweight or obese adults without diabetes.
Novo expects the label update for use in patients with an obesity-related common heart condition will be implemented shortly. It would allow use of the drug in patients suffering from obesity-related heart failure with preserved ejection fraction (HFpEF).
HFpEF is a condition in which heart muscles stiffen and draw in less blood. It accounts for about half of heart failure cases, with symptoms including shortness of breath and swelling in the extremities.
Data from a late-stage study showed patients lost weight after one year on Wegovy and had a 16.6-point improvement on a 100-point health scale based on a range of heart failure-related criteria.
It also improved physical limitations and exercise function in patients with the condition, Novo said.
The drug, chemically known as semaglutide, has been authorized in the European Union to treat obesity since 2022. The blockbuster drug belongs to a class of treatments known as GLP-1 agonists, which help regulate blood sugar and suppress appetite.
Novo's U.S. rival Eli Lilly's LLY.N drug tirzepatide is also approved for weight loss in the EU. Tirzepatide has shown to cut heart failure risk by 38% in a trial of preserved ejection fraction and obesity patients.
Novo reiterated it plans to resubmit Wegovy's data for easing heart failure in people with obesity to the U.S. Food and Drug Administration next year.
Reporting by Bhanvi Satija in Bengaluru; Editing by Shounak Dasgupta and Krishna Chandra Eluri
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