Pending approval from the European Commission, Novo Nordisk’s Ozempic is set to have the most comprehensive label in its class. The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended an update based on positive results from the STRIDE trial. This development positions Ozempic as a unique treatment with functional benefits for type 2 diabetes patients with peripheral arterial disease (PAD).
Ludovic Helfgott, executive vice president at Novo Nordisk, commented on the potential impact: “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.”
The recommendation follows data presented at the American Diabetes Association’s Scientific Sessions. The STRIDE trial demonstrated improvements in walking capacity among patients with type 2 diabetes and PAD. Additional findings from related trials were also shared.
Novo Nordisk anticipates that the European Commission will finalize the label update within two months. The company has also submitted requests for similar updates in other regions, including an expected decision from U.S. authorities by late 2025.
In addition to Ozempic developments, Novo Nordisk is seeking label expansion for Rybelsus based on SOUL trial data which indicates cardiovascular benefits. A decision regarding this application is anticipated later this year.
These advancements contribute to evidence supporting semaglutide across various conditions associated with type 2 diabetes and cardiovascular diseases.
