BAYRY - Bayer's kidney disease drug Kerendia gets Chinese regulator nod for expanded use

2023-05-18 04:47:29 ET

China's National Medical Products Administration (NMPA) approved the expanded use of Bayer's ( OTCPK:BAYRY ) ( OTCPK:BAYZF ) Kerendia to include earlier stages of chronic kidney disease (CKD) linked with type 2 diabetes (T2D) and reduce patient's risk of cardiovascular  (CV) events.

The label expansion include results on CV outcomes from a phase 3 trial called FIGARO-DKD which showed that Kerendia (finerenone) reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D.

The German conglomerate said Kerendia (10 mg or 20 mg) can now be used to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adult patients with CKD linked with T2D (with albuminuria).

Kerendia was initially approved by the NMPA in June 2022 — based on results from a phase 3 study called FIDELIO-DKD — to treat CKD (eGFR of ? 25 to 75 mL/min/1.73 m2 with albuminuria) linked with T2D in adults, to reduce the risk of sustained eGFR decline and end-stage kidney disease.

"The Chinese label update announced today endorses Kerendia as a cornerstone treatment offering physicians a distinct path to protect patients with chronic kidney disease associated with type 2 diabetes from further kidney damage and cardiovascular events," said Michael Devoy, chief medical officer, Bayer's Pharmaceuticals Division.

The drug was approved for this expanded use in EU in February.

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