New analysis on Mesoblast's rexlemestrocel-L could pave way for approval

Mesoblast (ASX: MSB) has provided new analyses from the DREAM-HF Phase III trial showing that the greatest treatment benefit from rexlemestrocel-L is in heart failure and low ejection fraction (HFrEF) patients with diabetes and/or ischemia, who are at high-risk of cardiovascular mortality, heart attacks or strokes.

In recent guidance to the Australian allogeneic cell therapy company, the US Food and Drug Administration (FDA) confirmed that reduction in incidence of cardiovascular mortality or irreversible morbidity is a clinically meaningful acceptable endpoint in patients with chronic HFrEF.

The agency encouraged Mesoblast to identify the highest-risk group with greatest likelihood of beneficial response to intervention with rexlemestrocel-L in the DREAM-HF Phase III trial.