EU regulator backs use of Novo's Wegovy to lower heart risks

(Reuters) -The European Medicines Agency has backed the use of Novo Nordisk's Wegovy to lower major heart risks and strokes in overweight or obese adults without diabetes, the Danish drugmaker said on Thursday.

The backing from the European Union drug watchdog's committee comes two days after Wegovy secured a similar nod from the UK regulator, while the U.S. Food and Drug Administration approved the drug for prevention of cardiovascular events in people with obesity earlier this year.

Novo said it will implement the updated use of Wegovy on its label, or prescribing information, in the EU within about one month.

The expanded use is supported by data from a late-stage trial that showed Wegovy reduced the risk of major cardiovascular events such as heart attack and stroke by 20% compared with placebo.

The trial enrolled 17,604 adults and was conducted in 41 countries, Novo said.

Novo's widely used diabetes drug Ozempic and weight-loss drug Wegovy, both chemically known as semaglutide, belong to a class of drugs called GLP-1 agonists.

Originally developed for type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly.

Soaring demand for GLP-1 agonists has led to supply constraints for drugmakers such as Novo Nordisk and rival Eli Lilly .

Supplies of both Novo's Wegovy and Lilly's weight loss drug Zepbound remain constrained, but the companies have been increasing production.

Novo's Wegovy was approved in the EU since 2022, and since June 2021 in the United States.

Analysts estimate sales of the drugs to reach $150 billion by the early 2030s.

Both Lilly and Novo are also testing their drugs for other health conditions.

(Reporting by Sriparna Roy and Bhanvi Satija in Bengaluru; Editing by Shailesh Kuber, Shinjini Ganguli and Devika Syamnath)