The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial.

STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life.

“People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum,” says Ludovic Helfgott, executive vice president, Product & Portfolio Strategy at Novo Nordisk. “Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events and improvement in functional walking capacity in people with type 2 diabetes. Coupled with its extensive real-world evidence, Ozempic offers best-in-class benefits for people living with type 2 diabetes and its comorbidities, helping to treat today’s disease, while potentially reducing future complications.”

US decision expected in last quarter of 2025

Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months. Novo Nordisk has also filed for a label expansion of Ozempic in the US, and a decision is expected in last quarter of 2025.

Rybelsus

Based on data from the SOUL trial, Novo Nordisk has also filed for a label expansion for Rybelsus with the EMA and FDA. This could potentially make Rybelsus the first and only oral GLP-1 RA with proven cardiovascular (CV) benefits. A decision is also expected in the second half of 2025.