On Monday, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approved an update to Novo Nordisk A/S‘ (NYSE:NVO) Rybelsus (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial.
SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsus on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Rybelsus is now the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA), mimicking a natural hormone in the body that helps regulate blood sugar, appetite, and digestion, available in the EU for type 2 diabetes with a proven cardiovascular benefit.
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The approval is based on results from the SOUL clinical trial, where oral semaglutide reduced cardiovascular death, heart attack, and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk.
New results from the SOUL trial will be shared later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.
These include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events compared with placebo.
Additional SOUL results will be presented at the same meeting, which highlight that the cardiovascular benefits of oral semaglutide were consistent regardless of body mass index (BMI) and body weight of participants.
In the U.S., a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus.
Novo Nordisk has also submitted an application in the U.S. for a once-daily 25 mg oral formulation of semaglutide (Wegovy in a pill) for adult patients with obesity or overweight and cardiovascular disease.
A decision is expected at the turn of this year, and if approved, Wegovy would become the first oral GLP-1 RA indicated for chronic weight management.
Rybelsus is the first and only oral GLP-1 RA approved for the treatment of type 2 diabetes, following its launch in 2019.
It is supported by a strong clinical and real-world evidence base, demonstrating superior blood glucose reduction and body weight reduction versus multiple comparators, as well as an established safety profile in people with type 2 diabetes.
Price Action: NVO stock is trading higher by 1.89% to $55.91 at last check Monday.
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