拜耳在欧盟递交非奈利酮用于慢性肾病伴糖尿病的适应症扩展申请

On March 16, 2022, Bayer announced that it had submitted a Class II change application to the European Medicines Agency to seek to expand the indications of fenelidone to cover patients with early-stage chronic kidney disease and type 2 diabetes. The application is based on positive data from the FIGARO-DKD study, which demonstrated a significant reduction in the risk of cardiovascular events in adults with chronic kidney disease and type 2 diabetes. The FIGARO-DKD study includes patients with a wide range of disease severity, including patients with stage 1-4 chronic kidney disease and type 2 diabetes. The findings were presented at the 2021 European Society of Cardiology Congress and also published in the New England Journal of Medicine.

Fenelidone is a non-steroidal MRA, officially named BAY94-8862. The results of a phase Ia clinical study show that, like spironolactone, Fenelidone can significantly reduce the NT-proBNP levels in patients with chronic heart failure and renal insufficiency with reduced ejection fraction. More importantly, it can simultaneously reduce the incidence of hyperkalemia and the occurrence of worsening renal function. In addition, in patients with chronic heart failure, type 2 diabetes, and/or chronic kidney disease with reduced ejection fraction, fenelinone and eplerenone have the same effect and can significantly reduce the level of NT-proBNP, but they can also moderately reduce the patient's mortality rate and cardiovascular hospitalization rate.

In the phase II clinical trial (ARTS), fenelidone had little effect on serum potassium and renal function in patients with heart failure combined with CKD/type 2 diabetes, and could effectively reduce NT-proBNP and proteinuria. In the recently announced phase III clinical study (FIDELIO-DKD), in patients with type 2 diabetes and CKD, based on the maximum tolerated dose of renin-angiotensin-aldosterone system (RAAS) blocker (ACEI/ARB) treatment, fenelidone significantly reduced the risk of renal composite endpoint events by 18% and the risk of cardiovascular composite key events by 14%.

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