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)