FDA approves new indication for finerenone in patients with HFmrEF/HFpEF
The non-steroidal MRA finerenone has received approval from the FDA for the treatment of adults with HF with mildly reduced or preserved ejection fraction (LVEF ≥40%).
Finerenone has been approved by the FDA to reduce the risk of CV mortality, HF hospitalization, and urgent HF visits in adults with HF with LVEF ≥40%. This decision by the FDA was based on the results of the phase 3 FINEARTS-HF trial.
FINEARTS-HF was an international, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of finerenone compared with placebo in 6001 patients with HFmrEF/HFpEF (NYHA class II-IV). In FINEARTS-HF, finerenone reduced the risk of the composite endpoint of CV mortality or total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits, compared with placebo.
Finerenone was previously approved in the U.S. for the treatment of adults with CKD associated with T2D to reduce the risk of kidney and CV complications. It is authorized in over 95 countries, including in China, Europe, and Japan, for this indication. Finerenone is not yet approved for HF with an LVEF of ≥40% outside the U.S. However, marketing authorization for this indication has been submitted in China, the EU, and Japan, and these applications are currently under review.