Novo Nordisk Receives Positive EMA Opinion to Update Ozempic Label With Risk Reduction of Kidney Disease-Related Events

MT Newswires Live

2024-12-14

Novo Nordisk (NVO) said Thursday it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for an update of the Ozempic, or semaglutide, label to include risk reduction of kidney disease progression in adults with type 2 diabetes and chronic kidney disease.

In the FLOW trial, which assessed how effectively Ozempic reduces the risk of chronic kidney disease-related events, semaglutide 1.0 milligram showed a "statistically significant and superior" 24% risk reduction in kidney disease progression, and cardiovascular and kidney death, versus placebo, the company said.

Additionally, Novo Nordisk said it has filed for a label expansion in the US, with a decision expected in H1 2025.

Shares of Novo Nordisk were down 2.4% in recent Friday trading.

Price: 105.98, Change: -2.63, Percent Change: -2.42

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