1.4.1-UACR-T1D

KERENDIA is the first proven treatment for CKD associated with T1D in more than 30 years

KERENDIA significantly reduced UACR vs placebo on top of standard of care

In the FOUNTAIN observational, retrospective analysis of KERENDIA

UACR reduction was observed in real-world clinical practice³²

Reductions in UACR were observed as early as Month 3 and were sustained through Month 6

KERENDIA for CKD in T2D

*Up to 3 daily UACR measures were combined into a geometric mean UACR prior to the analysis of the ratio to baseline of geometric mean UACR. ^†Assessment of data for the washout period was conducted using an ANCOVA model for the ratio to baseline in UACR at follow-up with the model including log baseline UACR. ^‡Geometric mean ratio of treatment group ratios to baseline over the study period (ie, average of geometric mean of treatment effect at month 3 and month 6 visits). ^§30 days after last dose of study intervention.

ANCOVA=analysis of covariance; BL=baseline; CI=confidence interval; CKD=chronic kidney disease; LSGM=least-squares geometric mean; T1D=type 1 diabetes; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

Trial Design 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; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HR=hazard ratio; RR=relative reduction; RRR=relative risk reduction; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

From The New England Journal of Medicine, Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in heart failure with mildly reduced or preserved ejection fraction, 391(16), 1475-1485. Copyright © 2024 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.¹⁰

CI=confidence interval; eGFR=estimated glomerular filtration rate; HF=heart failure; LVEF=left ventricular ejection fraction; NYHA=New York Heart Association.

REFERENCES

KERENDIA is the first proven treatment for CKD associated with T1D in more than 30 years

UACR reduction was observed in real-world clinical practice³²

Reductions in UACR were observed as early as Month 3 and were sustained through Month 6

Primary CV composite endpoint^1,25

Exploratory analysis¹

Primary renal composite endpoint¹

Exploratory analysis¹

Secondary CV composite endpoint¹

REFERENCES

KERENDIA is the first proven treatment for CKD associated with T1D in more than 30 years

UACR reduction was observed in real-world clinical practice32

Reductions in UACR were observed as early as Month 3 and were sustained through Month 6

Placebo-corrected UACR reduction was observed at month 4 and remained stable for the duration of the FIGARO-DKD trial1,31

Placebo-corrected UACR reduction was observed at month 4 and remained stable for the duration of the FIDELIO-DKD trial1,28

KERENDIA for CKD associated with T2D: efficacy and safety overview

Primary CV composite endpoint1,25

Exploratory analysis1

Secondary renal composite endpoint1,25

Primary renal composite endpoint1

Exploratory analysis1

Secondary CV composite endpoint1

Safety: pooled data FIGARO-DKD and FIDELIO-DKD1

KERENDIA showed a consistent treatment effect for the primary endpoint across all prespecified subgroups10

Select prespecified exploratory subgroups

While the underlying causes of T1D and T2D are different, the downstream effects in CKD are similar​

UACR reduction was observed in real-world clinical practice³²

Placebo-corrected UACR reduction was observed at month 4 and remained stable for the duration of the FIGARO-DKD trial^1,31

Placebo-corrected UACR reduction was observed at month 4 and remained stable for the duration of the FIDELIO-DKD trial^1,28

KERENDIA for CKD associated with T2D:
efficacy and safety overview

Primary CV composite endpoint^1,25

Exploratory analysis¹

Secondary renal composite endpoint^1,25

Primary renal composite endpoint¹

Exploratory analysis¹

Secondary CV composite endpoint¹

Safety: pooled data FIGARO-DKD and FIDELIO-DKD¹

KERENDIA showed a consistent treatment effect for the primary endpoint across all prespecified subgroups¹⁰

While the underlying causes of T1D and T2D are different, the downstream effects in CKD are similar