Shots:
The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications planned
Approval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where…
Shots:
The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned
Application was backed by P-III…
Shots:
Japan’s MHLW received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Regulatory review is ongoing in the US, EU & China, with global filings planned
Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n>15000)…
Shots:
The EMA received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits approval in US and China, with global applications planned
Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed…

