Bayer's Kerendia (finerenone) Receives the US FDA's Approval for the Treatment of Chronic Kidney Disease Associated with Type 2 Diabetes
- The approval is based on a P-III FIDELIO-DKD study evaluating finerenone (10/20mg) + SoC vs PBO + SoC in ~ 5700 patients with CKD & T2D. Patients were followed for a median of 2.6yrs.
- Results: reduction in the incidence of the primary composite EPs of a sustained decline in eGFR of ≥40%- reduction in kidney failure- renal death- CV death- non-fatal MI- non-fatal stroke- or hospitalization for HF
- Finerenone has been submitted for marketing authorization in the EU & China along with multiple other countries globally & is currently under review. The therapy is expected to be available in the US at the end of July’21
Ref: Bayer | Image: Bloomberg Quint
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