Novo Nordisk (NVO) said Monday a study of its Rybelsus oral semaglutide as an adjunct to the standard of care for preventing major adverse cardiovascular events met its primary goal.
The drugmaker said the study showed a statistically significant and superior reduction in major adverse cardiovascular events of 14% for people treated with oral semaglutide compared to placebo.
The study enrolled 9,650 people with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease.
Novo Nordisk said it expects to file for regulatory approval of a label expansion for Rybelsus in the US and EU around the turn of the year.
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