Overview
- India is the second market after the United States to clear Kerendia for heart failure with preserved or mildly reduced ejection fraction, with approval arriving within about three months of the U.S. decision, according to Bayer.
- The authorization covers patients with left ventricular ejection fraction above 40%, a population with limited proven therapies, and Bayer positions finerenone as an additional option alongside SGLT2 inhibitors.
- Company-cited Phase III data showed a 16% reduction in cardiovascular death and total heart-failure events for finerenone, with concurrent kidney protection reported.
- India participated in the late-stage global trials; Bayer will import the same German-made product and apply tiered pricing at roughly one dollar per day.
- Finerenone has been approved since 2022 for chronic kidney disease linked to type 2 diabetes, and filings for the new heart-failure use are under review in the EU, Japan and China; Bayer also reports Indian approval of haemophilia drug Jivi with launch expected early next year.