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October 20, 2025
1 min read
Key takeaways:
- The FDA approved oral semaglutide for primary and secondary prevention of CV events in high-risk adults with diabetes.
- Rybelsus is the first oral GLP-1 with a CV prevention indication in those with diabetes.
Novo Nordisk announced its oral GLP-1 has been approved by the FDA to reduce risk for major adverse cardiovascular events in high-risk adults with type 2 diabetes.
Approval of oral semaglutide (Rybelsus), which covers both the primary and secondary CVD prevention populations, was based on the positive results of the SOUL trial presented at presented at the American College of Cardiology Scientific Session and published in The New England Journal of Medicine.
SOUL was a double-blind, event-driven, superiority trial for which researchers enrolled 9,650 adults aged 50 years or older with type 2 diabetes and atherosclerotic CVD, chronic kidney disease or both, and randomly assigned them to oral semaglutide gradually titrated to the maximal dose (14 mg) or placebo.
As Healio previously reported, oral semaglutide reduced risk for major adverse CV events by 14% in high-risk adults with type 2 diabetes regardless of SGLT2 inhibitor use, with an overall safety profile similar to what has been observed in previous semaglutide trials.
Oral semaglutide is first oral GLP-1 to be FDA approved for primary and secondary prevention of CV death, heart attack or stroke in this patient population, according to a press release issued by Novo Nordisk.
John B. Buse
“Even in the absence of a previous heart attack or stroke, adults with type 2 diabetes face an increased risk of cardiovascular events, underscoring the need for therapies that go beyond managing blood sugar,” John B. Buse, MD, PhD, distinguished professor of medicine, director of the UNC Diabetes Care Center, and co-chair of the trial steering committee of SOUL, said in the release. “Having an oral GLP-1 therapy to help improve glycemic control was an innovation in and of itself. 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.”
In 2019, oral semaglutide was approved by the FDA for the treatment of type 2 diabetes based on the positive results of the PIONEER 2, 3 and 4 trials.
Sources/Disclosures
Source:
Disclosures:
Buse reports consulting for Altimmune, Amgen, ApStem, Aqua Medical, AstraZeneca, Boehringer Ingelheim, CeQur, Eli Lilly, Embecta, GentiBio Insulet Corp., Medtronic, Metsera, Tandem Diabetes Care, TERNS Pharmaceuticals, Vertex Pharmaceuticals and Zealand Pharma A/S; and having other financial ties with Corcept Therapeutics, Dexcom, Glyscend Therapeutics, Mellitus Health, Novo Nordisk, Pendulum Therapeutics, Praetego and Stability Health.
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