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Bayer submits marketing authorization applications for finerenone in the U.S. and the EU

1 min read

The FINANCIAL — Bayer announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that demonstrated renal and cardiovascular benefits in patients with CKD and T2D in the Phase III FIDELIO-DKD study. “Despite recent advances in treatment, many patients with chronic kidney disease and type 2 diabetes are still progressing to end-stage kidney failure or premature death,” said Professor George L. Bakris, MD,…

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Bayer submits marketing authorization applications for finerenone in the U.S. and the EU

1 min read

The FINANCIAL — Bayer announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that demonstrated renal and…

CHMP recommended approving Forxiga for heart failure treatment

2 mins read

The FINANCIAL — AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D). Heart failure (HF) is a life-threatening chronic disease in which the heart cannot pump…