Bayer: applies to market fineronone in Japan
(CercleFinance.com) - Bayer announces the submission of a marketing authorization application to the Japanese Ministry of Health for finerenone in chronic heart failure with a left ventricular ejection fraction (LVEF) ≥40%.
This treatment, a selective non-steroidal mineralocorticoid receptor antagonist, demonstrated cardiovascular benefits in this indication in the phase III FINEARTS-HF study.
Already marketed under the names Kerendia or Firialta, it is approved for chronic kidney disease associated with type 2 diabetes in over 90 countries.
The application is based on positive data from FINEARTS-HF and is part of the MOONRAKER program, which includes over 15,000 patients. Similar submissions are underway in China, the USA and the EU.
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