Finerenone hits in phase III but there are challenges ahead

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The hit in the first of finerenone’s diabetic kidney disease trials is a surprise, but with Bayer disclosing only that Fidelio-DKD was successful, without releasing the actual data, its significance is hard to determine. Should it reach the market Bayer’s mineralocorticoid receptor antagonist would go up against SGLT2 inhibitors; Johnson & Johnson’s Invokana is already approved for diabetic nephropathy on the back of a 32% placebo-adjusted reduction in risk of end-stage kidney disease. The endpoints of Invokana’s Credence trial do not line up with those of finerenone’s Fidelio-DKD study, however, so regulators and doctors will have to weigh the benefits carefully. Another SGLT2, Astrazeneca’s Farxiga, is due to yield data towards the end of this year in the phase III Dapa-CKD study in diabetics and non-diabetics with chronic kidney disease. A separate question for Bayer is whether finerenone can match the cardiovascular benefit Invokana has also shown in diabetics. Bayer’s Figaro-DKD trial of finerenone has the same endpoints as Fidelio-DKD, but prioritises the cardiovascular measure as the primary; it could report in a year or so. By then it should be clear whether the vast investment Bayer has made in finerenone’s diabetic nephropathy programme was worth it.

Finerenone vs Invokana in diabetic CKD patients 
Selected endpoints from Credence study of Invokana Risk reduction vs placebo: hazard ratio (p value)
Composite of end-stage kidney disease, doubling of serum creatinine, or renal or CV death* 0.70 (0.0001)
CV death 0.78 (0.05)
CV death or hospitalisation for heart failure  0.69 (<0.001)
CV death, myocardial infarction, or stroke 0.80 (0.01)
Selected endpoints from Fidelio-DKD study of finerenone Result
Time to first occurrence of composite of onset of kidney failure, sustained ≥40% decrease of eGFR or renal death* Reduced vs placebo
Time to first occurrence of composite of CV death or non-fatal myocardial infarction, stroke or hospitalisation for heart failure Reduced vs placebo
Time to first occurrence of composite of onset of kidney failure, sustained ≥57% decrease in eGFR or renal death Expected later this year
Time to all-cause death Expected later this year
*Primary endpoints. eGFR = estimated glomerular filtration rate. Source: NEJM and clinicaltrials.gov.

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