The US Food and Drug Administration has approved Novo Nordisk’s Rybelsus (oral semaglutide) to reduce the risk of major cardiovascular events — such as heart attack, stroke, or death — in adults with type 2 diabetes who are at high cardiovascular risk, even if they have never had a prior event.
The approval is based on results from the SOUL trial, which enrolled more than 9,600 participants. Over four years, the study found that oral semaglutide 14 mg lowered the risk of these serious heart-related outcomes by 14% compared with placebo, in addition to standard care.
Rybelsus is now the only oral GLP-1 therapy proven to reduce cardiovascular risk in people with type 2 diabetes. It can be used for both primary prevention (preventing a first heart event) and secondary prevention (reducing recurrence after one has occurred). The medicine, taken once daily at 7 mg or 14 mg, was first approved in 2019 to improve blood sugar control.
Novo Nordisk emphasized that this expanded indication reflects “a new benchmark for future oral innovations” in diabetes care and strengthens its ongoing work to integrate heart-health benefits into glucose-lowering treatments.
Sources
