Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

November 10, 2020 Auto Bot Bayer, EMA, finerenone, regulatory, Submits, Us FDA 0

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%

Click here ­to­ read full press release/ article | Ref: Bayer | Image: The Business Journals

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