- Mesoblast (ASX:MSB) receives U.S. FDA approval to accelerate rexlemestrocel-L (Revascor) for patients with end-stage ischemic heart failure and reduced ejection fraction (HFrEF) with a left ventricular assist device (LVAD)
- Feedback follows a Type B meeting on February 21, 2024, under the Regenerative Medicine Advanced Therapy (RMAT) designation
- Mesoblast’s, Revascor demonstrates reduced inflammation, increased weaning success, and lower mortality in ischemic HFrEF patients
- MSB last traded at at 10:30am AEDT
Mesoblast (ASX:MSB), a global leader in allogeneic cellular medicines, has received U.S. FDA approval to accelerate rexlemestrocel-L (Revascor) for patients with end-stage ischemic heart failure and reduced ejection fraction (HFrEF) with a left ventricular assist device (LVAD).
The feedback follows a Type B meeting on February 21, 2024, under the Regenerative Medicine Advanced Therapy (RMAT) designation.
“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” Mesoblast CEO Dr Silviu Itescu said.
“We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”
Chronic heart failure affects millions globally, in the U.S. alone, over 100,000 patients annually progress to end-stage HFrEF, with 2,500 plus receiving LVADs.
Mesoblast’s, Revascor has demonstrated reduced inflammation, increased weaning success, and lower mortality in ischemic HFrEF patients.
FDA feedback will prompt Mesoblast’s plan to request a pre-Biologics License Application (BLA) meeting.
MSB last traded at 33 cents, at 10:30am AEDT.