- The European Commission (EC) granted approval to extend the use of Bayer's ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) Kerendia to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and include results on cardiovascular (CV) outcomes from a phase 3 study called FIGARO-DKD.
- The German conglomerate said data from the study showed that Kerendia (finerenone) reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D.
- The company added that the extended EU-label for Kerendia now reflects data from more than 13K patients with CKD and T2D, based on the Phase 3 FIDELIO-DKD and FIGARO-DKD studies.
- Based on data from the FIDELIO-DKD study, Kerendia was granted initial marketing authorization by the EC in February 2022 to treat CKD (stage 3 and 4 with albuminuria) associated with T2D in adults, according to the company.
- "With Kerendia having demonstrated kidney and cardiovascular benefits across a broad spectrum of disease severity in the pivotal Phase III studies, today’s approval of the label extension supports the use of this drug also in patients with earlier stages of chronic kidney disease associated with type II diabetes," said Michael Devoy, chief medical officer of Bayer's Pharmaceuticals Division.
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Bayer's kidney disease drug Kerendia gets approval for expanded use in EU