Novo Nordisk: positive EU opinion for Ozempic
(CercleFinance.com) - Novo Nordisk has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for an update to the label of Ozempic ® (once-weekly subcutaneous semaglutide) to reflect data from the FLOW renal outcomes trial.
The FLOW trial assessed the risk reduction associated with Ozempic ® treatment in chronic kidney disease (CKD)-related events in adults with type 2 diabetes and chronic kidney disease (CKD).
In the FLOW trial, semaglutide 1.0 mg demonstrated a statistically significant and superior 24% reduction in the risk of kidney disease progression, cardiovascular and renal death compared to placebo.
In addition, the trial's secondary endpoints showed that the risk of major cardiovascular events was reduced by 18% and the risk of all-cause mortality was reduced by 20%.
Around 40% of people with type 2 diabetes develop chronic kidney disease. There is therefore a need for treatments that can help slow the progression of kidney disease, Novo Nordisk said.
With this positive opinion, Ozempic will become the first and only GLP-1 receptor agonist to show a reduced risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease. '
Novo Nordisk has also filed a label extension application in the US, and a decision is expected in H1 2025.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The FLOW trial assessed the risk reduction associated with Ozempic ® treatment in chronic kidney disease (CKD)-related events in adults with type 2 diabetes and chronic kidney disease (CKD).
In the FLOW trial, semaglutide 1.0 mg demonstrated a statistically significant and superior 24% reduction in the risk of kidney disease progression, cardiovascular and renal death compared to placebo.
In addition, the trial's secondary endpoints showed that the risk of major cardiovascular events was reduced by 18% and the risk of all-cause mortality was reduced by 20%.
Around 40% of people with type 2 diabetes develop chronic kidney disease. There is therefore a need for treatments that can help slow the progression of kidney disease, Novo Nordisk said.
With this positive opinion, Ozempic will become the first and only GLP-1 receptor agonist to show a reduced risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease. '
Novo Nordisk has also filed a label extension application in the US, and a decision is expected in H1 2025.
Copyright (c) 2024 CercleFinance.com. All rights reserved.