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Which regulatory agency will approve KERENDIA® for HFmrEF and HFpEF first by end of 2024?
2
Resolution / Starting Odds
FDA (US) • 25%
EMA (Europe) • 25%
PMDA (Japan) • 25%
Other • 25%
Regulatory agency announcements and press releases
Story
Bayer's Finerenone Achieves Primary Endpoint in Phase III HFmrEF and HFpEF Study
Aug 5, 2024, 06:40 AM
Bayer has announced that its Phase III FINEARTS-HF cardiovascular outcomes study investigating KERENDIA® (finerenone) in patients with heart failure with mildly reduced or preserved ejection fraction has achieved its primary endpoint. The study showed that finerenone, a non-steroidal MRA, demonstrated definitive cardiovascular benefits in patients with heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF), including reductions in CVd+total HF events. The results are seen as key to unlocking blockbuster sales for the drug. Full results will be presented at the upcoming ESC Congress.
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Similar markets
European Union • 25%
Japan • 25%
Canada • 25%
Other • 25%
European Medicines Agency (EMA) • 25%
Health Canada • 25%
Japan's PMDA • 25%
Other • 25%
FDA • 33%
EMA • 33%
Both • 34%
FDA (USA) • 25%
EMA (Europe) • 25%
MHRA (UK) • 25%
Other • 25%
FDA only • 25%
EMA only • 25%
Both FDA and EMA • 25%
Neither • 25%
Yes • 50%
No • 50%
Clinical hold • 25%
No action • 25%
Request for additional data • 25%
Other • 25%
European Central Bank • 25%
BaFin (Germany) • 25%
US SEC • 25%
Other • 25%
Yes • 50%
No • 50%
FDA (USA) • 25%
EMA (Europe) • 25%
MHRA (UK) • 25%
Other • 25%