Novo Nordisk Ozempic® Recommended in the EU for Peripheral Arterial Disease in Adults with Type 2 Diabetes
Tuesday, June 24, 2025
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to update the label of Ozempic® (semaglutide, once-weekly) based on data from the STRIDE trial.
Ozempic® is a once-weekly injectable GLP-1 RA used to improve blood sugar control and reduce the risk of major cardiovascular events in adults with type 2 diabetes and known heart disease. It is also the only GLP-1 RA with indications for reducing the risk of worsening kidney disease and cardiovascular death in people with type 2 diabetes and CKD. It is currently available in 72 countries and used by approximately 7 million people worldwide.
Rybelsus®, the oral version of semaglutide, is approved to improve glycaemic control in adults with type 2 diabetes. Available in 3 mg, 7 mg, and 14 mg doses, it is taken once daily. It has demonstrated superior blood glucose control and weight reduction compared to some other diabetes medications. Over 2.1 million people worldwide are currently being treated with Rybelsus®.
This update reflects the therapy’s benefit in improving functional outcomes in people with type 2 diabetes and peripheral arterial disease (PAD).
The STRIDE trial is the first of its kind to evaluate a glucagon-like peptide-1 receptor agonist (GLP-1 RA) specifically in this patient group. PAD is a type of atherosclerotic cardiovascular disease (ASCVD) that restricts blood flow to the limbs, often causing mobility issues and reduced quality of life.
With this update, Ozempic® would become the only GLP-1 RA supported by evidence of improving functional walking capacity in PAD, in addition to its previously demonstrated benefits in reducing risks of cardiovascular death, stroke, heart attack, major kidney events, and more. The label update is expected to be implemented by the European Commission within two months. Novo Nordisk has also filed for a similar label expansion in the US, with a decision anticipated in the last quarter of 2025.
The growing body of evidence supports the use of semaglutide across a range of cardiometabolic conditions, including type 2 diabetes, chronic kidney disease, metabolic dysfunction-associated steatohepatitis (MASH), obesity, and heart failure with preserved ejection fraction (HFpEF), both with and without type 2 diabetes. Semaglutide also maintains a well-established safety profile, with over 33 million patient-years of exposure since its launch in 2018.
The company has also submitted applications to extend the label of its oral GLP-1 RA, Rybelsus®, to include cardiovascular benefits, based on results from the SOUL trial. Decisions from both the EMA and the US FDA are expected in the second half of 2025.
Source: novonordisk.com
