KERENDIA (Bayer Australia Ltd)
Product name
KERENDIA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
175 (255 working days)
Active ingredients
finerenone
Registration type
EOI
Indication
Chronic Kidney Disease
KERENDIA is indicated to delay progressive decline of kidney function and to reduce the risk of cardiovascular mortality and morbidity in adults with chronic kidney disease (with albuminuria) associated with Type 2 diabetes, in addition to standard of care (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
Heart Failure
KERENDIA is indicated in adults for the treatment of symptomatic heart failure with left ventricular ejection fraction (LVEF) of ≥ 40%.