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EU drugs regulator to allow Novo Nordisk to include heart condition in Ozempic label
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EU drugs regulator to allow Novo Nordisk to include heart condition in Ozempic label
Jun 23, 2025 12:45 PM

June 23 (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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