- Bayer AG BAYRY reported disappointing results from its approved med Kerendia (finerenone) didn’t reach significance on all-cause mortality in a pooled analysis of two Phase 3 trials of the drug.
- Last July, the FDA approved the drug to slow chronic kidney disease progression in patients with CKD associated with type 2 diabetes.
- In a pooled analysis of the company’s Phase 3 FIDELIO-DKD and FIGARO-DKD studies, Kerendia did not reach statistical significance on all-cause or cardiovascular mortality.
- Bayer said the drug “narrowly missed” that mark and that an on-treatment analysis provided a more favorable picture.
- Related: Bristol Myers-JNJ Partnered Secondary Stroke Drug Misses Endpoint, But Companies See Enough Potential For Phase 3 Trials.
- Finerenone was found to reduce sudden cardiac death vs. placebo significantly.
- All-cause mortality rates were 8.5% in the Kerendia-treated group and 9.4% in the placebo.
- Bayer said CV mortality made up the most common cause of death in the trial, comprising 4.9% of the Kerendia group and 5.6% of the placebo group.
- Price Action: BAYRY shares are down 3.82% at $12.83 on the last check Monday.
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