(BAY 94-8862)

Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

(BAY 94-8862), Bayer, cardiovascular disease, chronic kidney disease, Clinical Trials, FIDELIO-DKD Study, finerenone, Inflammatory, Type 2 Diabetes / November 18, 2020 November 18, 2020

Shots: The P-III FIDELIO-DKD study in CKD and T2D enrolled over 13,000 patients with early kidney damage and more advanced stages of kidney disease. The data were presented at the ASN Kidney Week 2020 and published in the NEJM based on which Bayer submitted finerenone for marketing authorization in the US and the EU Results: …

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

(BAY 94-8862), Bayer, EMA, finerenone, regulatory, Regulatory Applications, Submits, Treat Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D), Us FDA / November 10, 2020 November 10, 2020

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 …