Shots:

• The MAA submitted to the EMA and the NDA to the US is based on P-III FIDELIO-DKD study assessing finerenone (10/20mg- qd) + SOC vs PBO in ~5-700 patients with CKD and T2D
• Result: reduction in the combined risk of time to kidney failure; a decrease of eGFR (≥ 40%) from baseline @4wks. or renal death by 18%- reduction in risk of 2EPs i.e. time to CV death- non-fatal MI- non-fatal stroke- or hospitalization for HF by 14% over a median duration of follow-up of 2.6yrs.
• Finerenone is a selective MRA- being evaluated in FIGARO-DKD study in ~7-400 patients with CKD and T2D. Bayer has also initiated P-III FINEARTS-HF study of finerenone in symptomatic HF patients with a left ventricular ejection fraction of ≥40%

 ­ Ref: Bayer | Image: The Business Journals