Novo Nordisk announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to update the Ozempic (once-weekly semaglutide) label, reflecting data from the STRIDE trial on functional outcomes in peripheral artery disease. The Danish pharmaceutical company expects the European Commission to implement the label update within approximately two months.
STRIDE Trial Demonstrates Functional Improvements
The positive opinion was based on data from a late-stage trial in which once-weekly semaglutide, the active ingredient in Ozempic, improved the maximum walking distance in people with type 2 diabetes with symptomatic peripheral artery disease. This represents a significant advancement in addressing functional limitations associated with this debilitating condition.
Peripheral artery disease (PAD) is a manifestation of atherosclerotic cardiovascular disease 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.
Regulatory Timeline and Global Expansion
Novo Nordisk has also filed for a label expansion of Ozempic in the US, with a decision expected in the last quarter of 2025. This parallel regulatory approach demonstrates the company's commitment to bringing these functional benefits to patients across major markets.
The EMA previously allowed Novo Nordisk to add risk reduction for events related to kidney disease to Ozempic's label last year, indicating a pattern of expanding therapeutic indications based on robust clinical evidence.
Rybelsus Cardiovascular Benefits Under Review
In addition to the Ozempic label expansion, Novo Nordisk has filed for a label expansion for Rybelsus with both the EMA and FDA. This could potentially make Rybelsus the first and only oral GLP-1 receptor agonist with proven cardiovascular benefits. A decision for Rybelsus is expected in the second half of 2025.
The potential approval would mark a significant milestone in diabetes care, offering patients an oral option with demonstrated cardiovascular protection, addressing a critical unmet need in the management of type 2 diabetes and associated cardiovascular complications.
