By Nicholas G. Miller

The Food and Drug Administration approved Novo Nordisk's oral GLP-1 medication to reduce the risk of major cardiovascular events in high-risk adults with type 2 diabetes.

The drug, called Rybelsus, is the only oral GLP-1 medication available. It was previously approved to treat type 2 diabetes but under the new approval, Novo Nordisk can now market the drug's benefits of reducing cardiovascular events.

European regulators granted Rybelsus similar approval earlier this year.

The FDA approval is based on a Phase 3 trial that found that the drug reduced the risk of major adverse cardiovascular events by 14% over four years among high-risk adults with type 2 diabetes.

The company has also submitted an application for its Wegovy drug to be approved for the treatment of obesity. A decision is expected later this year.

Write to Nicholas G. Miller at nicholas.miller@wsj.com

(END) Dow Jones Newswires

October 17, 2025 17:55 ET (21:55 GMT)

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