Bayer takes SGLT2 hopefuls head on with FDA approval for new kidney disease drug
The FDA on Friday approved Bayer Pharmaceuticals’ chronic kidney disease drug Kerendia (finerenone), the first and only nonsteroidal mineralocorticoid receptor antagonist, offering a new option for CKD. While rival SGLT2 inhibitors may dampen the market prospects for Kerendia, Bayer says the competition is misguided as it’s projecting at least $1 billion in annual sales.
The positive, placebo-controlled trial that led to the approval, published in the New England Journal of Medicine in December, showed how Kerendia significantly reduced the risks of CKD progression and cardiovascular events when compared with placebo. The treatment is now indicated to slow CKD progression, reduce the risk of end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, sustained eGFR decline, and hospitalization for heart failure in adults with CKD associated with type 2 diabetes.
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