Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion to update the label of Ozempic (once-weekly semaglutide) to include new data from the STRIDE trial, which focused on peripheral artery disease (PAD) outcomes.
PAD, a form of atherosclerotic cardiovascular disease (ASCVD), causes restricted blood flow to muscles, leading to pain, limited mobility, and reduced quality of life. The STRIDE trial is the only study of its kind to evaluate the impact of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) on functional outcomes in PAD patients.
Ludovic Helfgott, Executive Vice President of Product & Portfolio Strategy at Novo Nordisk, highlighted the significance of the update: “Pending European Commission approval, the STRIDE label update will make Ozempic the only GLP-1 RA proven to reduce risks of cardiovascular death, heart attack, stroke, major kidney events, and to improve walking ability in people with type 2 diabetes.”
Novo Nordisk expects the European Commission to finalize the label update within about two months. The company has also filed for a similar label expansion in the U.S., with a decision expected in late 2025.
In addition to STRIDE, Novo Nordisk presented secondary results from the SOUL and FLOW trials at the American Diabetes Association’s 85th Scientific Sessions:
- SOUL showed enhanced cardiovascular benefits of oral semaglutide in patients with type 2 diabetes and cardiovascular or kidney disease, particularly those with higher baseline HbA1c levels.
- FLOW demonstrated kidney benefits of once-weekly semaglutide in patients with type 2 diabetes and chronic kidney disease, benefits which were independent of body weight changes. The study also projected semaglutide’s long-term cost-effectiveness in this population.
These findings further strengthen the role of semaglutide in managing a broad 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).
Since its launch in 2018, semaglutide has been used in more than 33 million patient-years across various indications, maintaining a well-established safety profile.
The updated Ozempic label is expected to provide physicians and patients with greater confidence in addressing the complex needs of people living with type 2 diabetes and related comorbidities.