FDA approves oral semaglutide for reducing cardiovascular risks in adults with type 2 diabetes
The U.S. Food and Drug Administration (FDA) has approved Rybelsus, Novo Nordisk’s oral semaglutide formulation, for reducing the risk of major adverse cardiovascular events in high-risk patients with type 2 diabetes. Rybelsus is officially the first oral GLP-1 drug approved for this indication.
The FDA’s decision was largely based on data from the SOUL trial, which included data from more than 9,000 patients who were randomized to oral semaglutide or a placebo.[1] All patients had type 2 diabetes in addition to known atherosclerotic cardiovascular disease, chronic kidney disease or both. Overall, the study’s primary outcome—a composite of cardiovascular death, nonfatal heart attack or nonfatal stroke—was seen in 12% of oral semaglutide patients and 13.8% of placebo patients. This represents a 14% overall reduction, similar to the results associated with injectable semaglutide.
The FDA originally approved Rybelsus in 2019 to improve glycemic control in adults with type 2 diabetes. At the time, it was the celebrated as the first GLP-1 drug available in pill form—and it still is six years later.
Darren K. McGuire, MD, a professor of medicine at UT Southwestern Medical Center, presents late-breaking clinical data on the cardiovascular benefits of oral semaglutide during ACC.25 in Chicago.
“Having an oral GLP-1 therapy to help improve glycemic control was an innovation in and of itself,” SOUL senior author John B. Buse, MD, PhD, a professor with the UNC School of Medicine and director of the UNC Diabetes Care Center, said in a statement. “This new indication, based on the SOUL data, marks even further advancement and showcases the versatility of semaglutide while expanding options for millions of people.”
“As the only FDA-approved GLP-1 therapy in a pill, now recognized for its proven cardiovascular benefits, a new benchmark has been set for future oral innovations,” added Dave Moore, executive vice president of US Operations for Novo Nordisk. “The semaglutide molecule has consistently demonstrated robust outcomes across multiple, large-scale trials, further reinforcing the already established cardiovascular profile it delivers for patients.”
Darren K. McGuire, MD, SOUL lead author and a professor of medicine at UT Southwestern Medical Center, first shared these findings at ACC.25, the annual meeting of the American College of Cardiology.
Novo Nordisk has also submitted an application to the FDA for a once-daily oral formulation of semaglutide to be approved for the treatment of obesity. If approved, it would be sold under the established brand name Wegovy.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.