1.4.2-CV

In adult patients with CKD associated with T2D

KERENDIA is proven to reduce the risk of CV events on top of standard of care^1,19

FIGARO-DKD

FIDELIO-DKD

FIGARO-DKD TRIAL

Primary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF¹

Primary Composite Endpoint

13% RRR vs placebo¹

HR=0.87 | 95% CI: 0.76-0.98 | P=0.026

HHF¹
29% RRR

HR=0.71
(95% CI: 0.56-0.90)

CV death¹
10% RRR

HR=0.90
(95% CI: 0.73-1.08)

ARR: 2.1%

(95% CI: 0.4-3.8)²

NNT: 47

(95% CI: 26-226)
to prevent a primary composite endpoint event at 42 months²

The treatment effect was mainly driven by an effect on hospitalization for HF, though CV death contributed¹
Individual components of the composite endpoint were exploratory in nature and not adjusted for multiplicity¹
KERENDIA is not indicated to reduce the risk of nonfatal stroke¹

Subgroups

KERENDIA for HF LVEF ≥40%

ARR=absolute risk reduction; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; HF=heart failure; HF LVEF=heart failure with left ventricular ejection fraction; HHF=hospitalization for heart failure; HR=hazard ratio; MI=myocardial infarction; NNT=number needed to treat; RRR=relative risk reduction; T2D=type 2 diabetes.

FIDELIO-DKD TRIAL

Key secondary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF¹

Secondary Composite Endpoint

14% RRR vs placebo¹

HR=0.86 | 95% CI: 0.75-0.99 | P=0.034

HHF¹
14% RRR

HR=0.86
(95% CI: 0.68-1.08)

CV death¹
14% RRR

HR=0.86
(95% CI: 0.68-1.08)

Nonfatal MI¹
20% RRR

HR=0.80
(95% CI: 0.58-1.09)

ARR: 2.4%

(95% CI: 0.3-4.5)²⁸

NNT: 42

(95% CI: 22-397)
to prevent a key secondary composite endpoint event at 36 months²⁸

The treatment effect reflected a reduction in CV death, nonfatal MI, and HHF¹
Individual components of the composite endpoint were exploratory in nature and not adjusted for multiplicity¹
KERENDIA is not indicated to reduce the risk of nonfatal stroke¹

Subgroups

KERENDIA for HF LVEF ≥40%

ARR=absolute risk reduction; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; HF LVEF=heart failure with left ventricular ejection fraction; HHF=hospitalization for heart failure; HR=hazard ratio; MI=myocardial infarction; NNT=number needed to treat; RRR=relative risk reduction; T2D=type 2 diabetes.

Trial Design CV Data Renal Data UACR Safety

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Hypersensitivity to any component of this product
Concomitant use with strong CYP3A4 inhibitors
Patients with adrenal insufficiency

WARNINGS AND PRECAUTIONS:

Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia

Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.
Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed

Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m² is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function

MOST COMMON ADVERSE REACTIONS:

CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

DRUG INTERACTIONS:

Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.
Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS:

Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

INDICATIONS:

KERENDIA (finerenone) is indicated to reduce the risk of:

sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

Please see the full Prescribing Information for KERENDIA.

CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; GLP-1=glucagon-like peptide-1; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

REFERENCES

KERENDIA is proven to reduce the risk of CV events on top of standard of care1,19

FIGARO-DKD TRIAL

Primary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF1

FIDELIO-DKD TRIAL

Key secondary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF1

The treatment effect with KERENDIA was generally consistent across subgroups1,30

Prespecified, exploratory subgroups included:

SGLT2i use at baseline

GLP-1 use at baseline

UACR at baseline

eGFR at baseline

KERENDIA is proven to reduce the risk of CV events on top of standard of care^1,19

Primary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF¹

Key secondary composite endpoint consisted of CV death, nonfatal MI, nonfatal stroke, or HHF¹

The treatment effect with KERENDIA was generally consistent across subgroups^1,30