EU panel backs Ozempic label update for peripheral artery disease

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to update the Ozempic label with data from the STRIDE trial in peripheral artery disease (PAD), Novo Nordisk said in an announcement dated June 23, 2025 ^[1]. The recommendation now goes to the European Commission, which the company expects to implement the label change in about two months ^[1].

STRIDE enrolled 792 people with type 2 diabetes and symptomatic PAD who had leg pain brought on by walking ^[1]. It was a double-blind, randomized, placebo-controlled phase 3b trial that measured how far participants could walk on a treadmill set to a steep 12% incline at week 52 ^[1]. Semaglutide 1.0 mg produced a 13% improvement in maximum walking distance compared with placebo, a mean treatment difference of 39.9 meters ^[1]. Secondary results presented at the American Diabetes Association's 85th Scientific Sessions showed the improvement was consistent regardless of participants' type 2 diabetes characteristics ^[1].

If the European Commission agrees, Ozempic would become the first glucose-lowering medicine with proven functional benefit in people with type 2 diabetes and PAD, and would carry the broadest approved label in the GLP-1 receptor agonist class, according to the company ^[1]. That class includes other semaglutide products, such as Wegovy and Rybelsus, and the tirzepatide products Mounjaro and Zepbound ^[1].

PAD affects about 230 million people worldwide and is described in the announcement as under-screened and under-diagnosed; nearly one in three people with PAD also has type 2 diabetes ^[1]. Anti-atherosclerotic therapies and lifestyle changes are recommended, but there are no therapies specifically aimed at improving functional outcomes in PAD with type 2 diabetes, the company said ^[1].

Ozempic is already indicated in adults with type 2 diabetes, along with diet and exercise, to improve blood sugar, to reduce the risk of major cardiovascular events such as heart attack, stroke or death in those with known heart disease, and to reduce the risk of worsening kidney disease and cardiovascular death in those with chronic kidney disease ^[1]. It is marketed in 72 countries, and about 7 million people with type 2 diabetes are currently treated with it worldwide, according to the company ^[1].

Why it matters for patients

A label update changes what regulators say a medicine is proven to do. It does not by itself change insurance coverage or what any doctor prescribes. For patients in Europe who have type 2 diabetes and PAD, the change would put a walking-capacity benefit into the official product information. For patients in the United States, nothing has changed yet.

The distinction matters because PAD symptoms, including leg pain or cramping with walking, can limit activity and quality of life, and the condition is often missed ^[1]. The trial did not test semaglutide in people without PAD, and it did not compare semaglutide with other GLP-1 medicines. The results apply to the group studied: people with type 2 diabetes and symptomatic PAD with walking-induced leg pain, treated with once-weekly semaglutide 1.0 mg on top of standard care ^[1].

Whether US insurers would cover Ozempic expressly for PAD-related walking limits has not been reported. The company describes semaglutide's safety profile as well established, with more than 33 million patient-years of exposure across indications since its launch in 2018 ^[1].

What happens next

• European Commission decision on the Ozempic label update is expected within approximately two months of the June 23, 2025 opinion ^[1].
• Novo Nordisk has filed for a US label expansion for Ozempic, with a decision expected in the last quarter of 2025 ^[1].
• The company has also filed with the EMA and FDA for a Rybelsus (oral semaglutide) label expansion based on the SOUL cardiovascular outcomes trial, which enrolled 9,650 people and showed a 14% reduction in major adverse cardiovascular events; decisions are expected in the second half of 2025 ^[1].