Kerendia (finerenone)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- finerenone
- Company
- Bayer AG
- Status
- Authorised
- Therapeutic area
- Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Heart Failure
- CHMP opinion
- Thu 16 Dec 2021
- EU approval
- Wed 16 Feb 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005200
- ATC
- C09
- Official record
- www.ema.europa.eu
Indication
Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. For study results with respect to renal and cardiovascular events, see section 5.1. Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.
Regulatory milestones
No milestones recorded in the last year.
Follow Kerendia
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.