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Unassigned

New Medicines

Treatment of diabetic kidney disease in patients with type 2 diabetes mellitus (stage 3 and 4 with albuminuria) to reduce risk of cardiovascular mortality/morbidity and rate of progression of kidney disease

Information

New molecular entity
Bayer
Bayer

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Approved (Licensed)
Jul 21Approved in US [13]
Jan 21US FDA grants priority review [12]
Nov 20Bayer announces submission of a New Drug Application (NDA) to the U.S. FDA and a Marketing Authorization Application to the EMA seeking approval of finerenone for patients with chronic kidney disease and type 2 diabetes [10].

Category

Mineralocorticoid receptor antagonist, blocks the deletorious effects of aldosterone [1]
Estimates for the prevalence of kidney disease as a result of diabetes vary from around 18% to over 30%. The proportion of people with diabetes with end stage renal disease is increasing. In 2008-9 figures of 1.3% and 0.5% were reported for type 1 and type 2 diabetes which would translate to approximately 2500 people with type 1 diabetes and 9000 people with type 2 diabetes who may require dialysis or kidney transplantation [2].
Treatment of diabetic kidney disease in patients with type 2 diabetes mellitus (stage 3 and 4 with albuminuria) to reduce risk of cardiovascular mortality/morbidity and rate of progression of kidney disease
Oral

Trial or other data

Nov 20Further new data announced from pre-specified exploratory subgroup analysis of the FIDELIO-DKD PIII study in pts with a history of cardiovascular disease (CVD). In 2,605 pts with a history of CVD, a lower proportion of in the finerenone arm experienced the composite cardiovascular outcome vs. placebo (17.7 vs 20.2%; hazard ratio [HR]=0.85; 95% CI, 0.71–1.01). Similar observations were seen in 3,069 pts without a history of CVD (8.9 for finerenone vs. 10.2% for placebo; HR=0.86; 95% CI, 0.68–1.08). Finerenone also significantly reduced composite time to CV death, non-fatal MI, non-fatal stroke or hospitalisation for heart failure vs. placebo (HR=0.86; 95% CI, 0.75-0.99; p=0.0339) over a median follow-up period of 2.6 years.[11]
Oct 20PIII FIDELIO-DKD is published; in 5734 pts with chronic kidney disease (CKD) and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression (40% baseline reduction eGFR or death from renal causes) vs placebo (follow up 2.6 yrs; 17.8% vs 21.1%; HR 0.82; 95% CI, 0.73 to 0.93; P=0.001) [9].
Jul 20PIII FIDELIO-DKD (NCT02540993) has posted top line results demonstrating that finerenone is superior to placebo at delaying the composite primary endpoint of onset of kidney failure, sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks or renal death. The study also showed superiority of finerenone over placebo for one of the five secondary outcomes (composite of time to first fatal or non-fatal CV event) [7,8].
Dec 19PIII FIGARO-DKD (NCT02545049) and FIDELIO-DKD (NCT02540993) trials are ongoing, with an estimated primary completion date of Apr 20 and Jun 21, respectively [6].
Dec 18The PIII FIDELIO-DKD and FIGARO-DKD trials are ongoing, with an estimated primary completion date of Apr 20 and Jun 21, respectively. [5]
Dec 16The PIII FIGARO-DKD and FIDELIO-DKD trials are still recruiting subjects [4]
Nov 15Bayer initiate PIII RCT (NCT02545049; EudraCT2015-000950-39; FIGARO-DKD) to investigate the efficacy and safety of finerenone on the reduction of cardiovascular morbidity and mortality in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease in addition to SoC. The primary outcome is time to first occurrence of the composite endpoint of CV death or non-fatal CV event (i.e. myocardial infarction, stroke, or hospitalization for HF) [3].
Sep 15Bayer initiate PIII RCT (EudraCT 2015-000990-11; NCT02540993) to investigate the safety and efficacy of finerenone in addition to SoC on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease. The primary endpoint is time to first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death [3].
Sep 15Two multinational PIII trials, FIGARO-DKD (n=6,400) and FIDELIO-DKD (n=4,800), are planned based on data from the phase IIb ARTS-DN study (NCT01874431) to assess the efficacy and safety of finerenone in patients with DKD, mainly comprising of patients with high albuminuria. In both the studies, patients will receive finerenone or placebo along with standard-of-care (SOC) therapy, including RAS-blocking therapy such as angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) [1,3].

Evidence based evaluations

Treatment of diabetic kidney disease in patients with type 2 diabetes mellitus to reduce risk of cardiovascular mortality/morbidity and rate of progression of kidney disease

Information

Licence extension / variation
Bayer
Bayer

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Mineralocorticoid receptor antagonist, blocks the deletorious effects of aldosterone [1]. Dose is 10mg or 20mg, once daily.
Estimates for the prevalence of kidney disease as a result of diabetes vary from around 18% to over 30%. The proportion of people with diabetes with end stage renal disease is increasing. In 2008-9 figures of 1.3% and 0.5% were reported for type 1 and type 2 diabetes which would translate to approximately 2500 people with type 1 diabetes and 9000 people with type 2 diabetes who may require dialysis or kidney transplantation [2].
Treatment of diabetic kidney disease in patients with type 2 diabetes mellitus to reduce risk of cardiovascular mortality/morbidity and rate of progression of kidney disease
Oral

Further information

Yes
To be confirmed

Evidence based evaluations

Heart failure and left ventricular ejection fraction ≥40%

Information

Licence extension / variation
Bayer
Bayer

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Mineralocorticoid receptor antagonist, blocks the deletorious effects of aldosterone
Currently around 920,000 people in the UK have a diagnosis of heart failure. Prevalence in developed countries is approximately 1-2% of the adult population, increasing to 10% or more in those over 70 years of age. It is increasingly prevalent with increasing age. The average age at diagnosis is 77. People with HFpEF are more likely to be older and female than those with HFrEF [1].
Heart failure and left ventricular ejection fraction ≥40%
Oral