A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

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.

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