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 […]
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Europe allows Novo to include reduction of kidney disease in Ozempic label
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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)