FDA approves SGLT2 inhibitor for CKDNews - Sep. 25, 2023
The FDA approved the SGLT2 inhibitor empagliflozin for the treatment of adults with CKD to reduce the risk of sustained decline in eGFR, end-stage kidney disease, CV death and hospitalization. This decision by the FDA expands the previous indication of empagliflozin for the treatment of adults with HF and T2D. The FDA based their approval on the results of the EMPA-KIDNEY trial.
The EMPA-KIDNEY trial was a multinational, randomized, double-blind, placebo-controlled, phase 3 clinical trial, in which 6609 patients with CKD were randomized to 10 mg empagliflozin or placebo, once daily, on top of standard care. Inclusion criteria were: eGFR ≥20 to<45 mL/min/1.73 m² or an eGFR ≥45 to < 90 mL/min/1.73 m² with a urine albumin to creatine ratio of ≥200 mg/g. In EMPA-KIDNEY, empagliflozin on top of standard care reduced the risk of the composite primary endpoint of kidney disease progression or CV death by 28% compared with placebo (HR=0.72; 95%CI: 0.64-0.82). Moreover, empagliflozin reduced the risk of first and recurrent hospitalization compared with placebo (HR=0.86; 95%CI:0.78-0.95).