FDA approves Novo Nordisk's oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event

发布时间： 2025-10-23 阅读：58次

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Oct. 17, 2025 -- Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved Rybelsus®, the only oral GLP-1 medication available, for reducing the risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior CV event or not (primary and secondary prevention).

In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to placebo, in addition to standard therapies.

Separately, Novo Nordisk has also submitted an application in the US for a once-daily oral formulation of semaglutide under the trade name Wegovy® for the treatment of obesity. A decision is expected later this year.