(Reuters) -Novo Nordisk said on Monday the European drugs regulator will allow a label update for its diabetes drug Ozempic to include a condition called peripheral artery disease.
The company said the European Medicines Agency’s positive opinion on the label update 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.
The condition is caused due to a buildup of fatty deposits in the artery walls that restricts blood supply to muscles, causing debilitating symptoms, physical limitations and poor quality of life.
Novo Nordisk expects the European Commission to implement the label update in about two months.
The drugmaker has also filed for a label expansion of Ozempic in the U.S., and a decision is expected in the last quarter of 2025, it said.
The EMA last year allowed Novo to add risk reduction for events related to kidney disease to Ozempic’s label.
(Reporting by Siddhi Mahatole and Sneha S K in Bengaluru; Editing by Shinjini Ganguli)
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