Bayer's Kerendia gets broader use in diabetic kidney disease

Bayer's Kerendia has had its label extended in the US to include chronic kidney disease (CKD) associated with type 1 diabetes (T1D), becoming the first new therapy for these patients in around 30 years.

Mineralocorticoid receptor antagonist (MRA) Kerendia (finerenone) – one of Bayer's top growth prospects – is already approved to treat CKD in patients with type 2 diabetes (T2D) and heart failure, and sales in the first half of this year rose 75% to more than €600 million.

The new indication could lend further momentum to the product and comes on the back of the phase 3 FINE-ONE study, which showed that adding Kerendia to standard care for patients with T1D and CKD resulted in a significantly greater decrease in the urinary albumin-to-creatinine ratio (UACR) – a biomarker for kidney damage – compared to placebo.

Published in the New England Journal of Medicine in March, the 242-subject trial found that after six months, Kerendia reduced the UACR by 25% from baseline over six months and also improved estimated glomerular filtration rate (EGFR), a measure of kidney function.

While T1D is a smaller market than T2D, it remains a sizeable opportunity, as approximately 30% of people with T1D in the US eventually develop CKD, increasing their risk of kidney failure and cardiovascular events.

The new approval will lend additional momentum to the brand as Bayer also works towards a further extension of its label to include non-diabetic patients with CKD, based on the results of the FIND-CKD study.

FIND-CKD, which enrolled patients with CKD associated with high blood pressure and other conditions like chronic glomerulonephritis, met its primary goal by showing that finerenone significantly slowed the annual rate of decline in EGFR compared to placebo when added to standard-of-care treatment.

Bayer's official peak annual sales estimate for finerenone (Kerendia) across all indications is more than €3 billion, making it a key product for the company, as it is relying on the drug and a handful of other new products like prostate cancer therapy Nubeqa (darolutamide) and recently approved Hyrnuo (sevabertinib) for ER2-mutant non-small cell lung cancer (NSCLC).

It needs the new products to perform so as to help it weather the loss of patent protection and declining sales for anticoagulant Xarelto (rivaroxaban), as well as competitive pressure on eye drug Eylea (aflibercept).