FDA Expands Approval of Rybelsus®: Oral Diabetes Medication Now Proven to Reduce Cardiovascular Risk
Washington D.C. – the U.S. Food and Drug Administration (FDA) today announced an expanded approval for Rybelsus® (oral semaglutide), making it the only oral glucagon-like peptide-1 (GLP-1) receptor agonist in the United States authorized to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes. This approval applies to patients at increased risk of these events, regardless of whether they have previously experienced a heart attack or stroke.
MACE primarily encompasses myocardial infarction (heart attack) and stroke. the decision stems from positive results from the phase 3 SOUL clinical trial, demonstrating a significant benefit beyond blood sugar control for this vulnerable patient population.
This expanded indication covers both primary prevention – reducing the risk of cardiovascular events in high-risk individuals before a first event – and secondary prevention - lowering the risk of repeat events in those with a prior history.
“Even in the absence of a previous heart attack or stroke, adults with type 2 diabetes are at increased risk for cardiovascular events, underscoring the need for therapies that go beyond glycemic control,” stated Dr.John B. Buse, director of the UNC Diabetes Care Center and co-chair of the SOUL study’s steering committee.
The SOUL trial evaluated the impact of oral semaglutide 14 mg, in conjunction with standard care, on MACE risk in adults with type 2 diabetes already at elevated risk.Results showed a statistically significant 14% reduction in the risk of MACE over four years compared to a placebo group, with a safety profile consistent with previous studies.
Rybelsus® was initially approved in 2019 as a treatment to improve glycemic control in adults with type 2 diabetes, used in combination with diet and exercise.
This move aligns with a similar recent decision in the European Union, where the committee for Medicinal products for Human Use (CHMP) of the European Medicines Agency (EMA) also recommended approval for this expanded indication last month.
