Bayer has submitted a New Drug Application (NDA) to China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), seeking approval to expand the use of finerenone to adult patients with non-diabetic chronic kidney disease (CKD).

 

The submission is backed by positive findings from the Phase III FIND-CKD study, which provides new evidence supporting finerenone’s potential role in slowing disease progression and reducing cardiovascular risks among patients with non-diabetic forms of CKD.

 

An estimated 850 million people worldwide are living with CKD, with more than half affected by non-diabetic CKD. Despite current standards of care, many of these patients remain at risk of kidney failure and serious cardiovascular complications.

 

Patients with advanced non-diabetic CKD face a significantly elevated risk of cardiovascular death, with the risk estimated to be about 2.6 times higher than in people without CKD and increasing as kidney function declines.

 

“People living with non-diabetic chronic kidney disease (CKD) face a substantial risk for progressive kidney function decline and cardiovascular events. The FIND-CKD study adds robust evidence supporting the potential of finerenone to address this risk across a diverse range of non-diabetic CKD etiologies, including CKD due to hypertension and glomerular diseases,” said Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division.

 

“Building on the evidence generated across the finerenone clinical development program, the submission of these data marks an important step in our efforts to bring finerenone to more patients who may benefit from its cardio-kidney protective effects and reflects our commitment to advancing innovation for people living with heart and kidney diseases worldwide.”

 

Since 2021, finerenone has been marketed as Kerendia or, in selected countries, as Firialta, and has been approved for adults with CKD associated with type 2 diabetes (T2D) in more than 100 countries, including China, Europe, Japan, and the United States.

 

The medicine is also approved for treating heart failure with left ventricular ejection fraction (LVEF) of 40% or higher in the U.S., European Union, Japan, and China, with additional regulatory applications currently under review.

 

The latest filing marks a further step in Bayer’s efforts to expand access to finerenone and address unmet needs among people living with chronic heart and kidney diseases.