EU regulators back an Ozempic label update for peripheral artery disease

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on June 23, 2025, recommending an update to the Ozempic label to include data on peripheral artery disease (PAD) ^[1]. The recommendation is based on results from the STRIDE trial, and Novo Nordisk says it makes semaglutide the first glucose-lowering treatment with proven functional benefit for people with type 2 diabetes and PAD ^[1].

STRIDE was a phase 3b trial that enrolled 792 people with type 2 diabetes and symptomatic PAD, a condition where fatty buildup in artery walls restricts blood flow to the legs and can cause pain while walking ^[1]. The trial measured maximum walking distance on a treadmill set to a steep 12% incline. At week 52, people taking semaglutide 1.0 mg showed a 13% improvement in walking distance compared with placebo, a mean difference of 39.9 meters ^[1]. Secondary results presented at the American Diabetes Association's 85th Scientific Sessions showed the walking improvement held up consistently regardless of participants' other type 2 diabetes characteristics ^[1].

PAD affects roughly 230 million people worldwide, and nearly one in three people with PAD also has type 2 diabetes, according to Novo Nordisk ^[1]. The company says no other therapy currently on the market has been shown to specifically improve functional walking outcomes in people who have both PAD and type 2 diabetes ^[1].

This is not yet a final approval. The CHMP opinion goes to the European Commission, which Novo Nordisk expects to formally implement the label update within about two months ^[1]. If it does, Ozempic would carry the broadest label in its drug class in Europe, covering blood sugar control, weight, cardiovascular events, chronic kidney disease, and now PAD walking function ^[1].

Why it matters for patients

For people in the US who take Ozempic for type 2 diabetes, this EU action does not change what's printed on the label here. Novo Nordisk has separately filed for the same PAD label expansion with the FDA, and the company expects a decision from US regulators in the last quarter of 2025 ^[1]. Until the FDA acts, Ozempic's US label does not include PAD claims.

The underlying data may still be relevant to conversations between patients and clinicians, since PAD is common among people with type 2 diabetes and can cause significant leg pain and reduced mobility ^[1]. A treatment shown to improve walking distance in a controlled trial adds to the evidence base, even before it appears on a US label.

It's also worth noting what STRIDE did and did not measure. The trial tracked walking distance on a treadmill, not broader outcomes like amputation rates or long-term disability, based on what's described in the available material. Whether the walking improvement translates into other real-world benefits is not addressed in these sources.

What happens next

The European Commission is expected to formally decide on the label update within roughly two months of the June 23 CHMP opinion, putting a decision around late August 2025 ^[1]. In the US, the FDA is expected to rule on Novo Nordisk's separate PAD label application for Ozempic in the fourth quarter of 2025 ^[1]. Separately, the company has also filed for a label update to Rybelsus, its oral semaglutide pill, based on cardiovascular outcomes from the SOUL trial, with decisions from both the EMA and FDA expected in the second half of 2025 ^[1]. None of these filings affect Wegovy, tirzepatide products like Mounjaro or Zepbound, or orforglipron (Foundayo), which are different molecules not covered by this action.