Published by Global Banking & Finance Review®
Posted on December 12, 2024
1 min readLast updated: January 27, 2026
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EMA approves Novo Nordisk's Ozempic label update to include kidney disease risk reduction, following successful trial results. US decision expected by 2025.
HELSINKI (Reuters) - The European Medicines Agency (EMA) will allow Novo Nordisk to add risk reduction for events related to kidney disease to the label of its diabetes drug Ozempic, the Danish drugmaker said in a statement on Thursday.
The label update is based on a trial where Novo demonstrated that the use of semaglutide reduced the risk of kidney disease progression, Novo added.
The company is also expecting to hear back from an application to update Ozempic's label in the United States during the first half of 2025, it said.
(Reporting by Essi Lehto, editing by Louise Rasmussen and Terje Solsvik)
The main topic is the EMA's approval for Novo Nordisk to update Ozempic's label to include kidney disease risk reduction.
The trial demonstrated that semaglutide reduces the risk of kidney disease progression.
Novo Nordisk expects to hear back from the US regarding the label update in the first half of 2025.
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