https://endpts.com/a-top-drug-program-at-bayer-clears-a-high-bar-for-ckd-opening-the-door-to-an-fda-pitch/

October 23, 2020 10:30 AM EDT
 
 
A top drug program at Bayer clears a high bar for CKD — opening the door to an FDA pitch

John Carroll

Editor & Founder
 

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.