MESO

Mesoblast : FDA Backs Accelerated Approval For Rexlemestrocel-L In Heart Failure Patients

(RTTNews) - Mesoblast Limited (MESO, MSB.AX) said that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast's allogeneic mesenchymal precursor cell or MPC product, in patients with end-stage ischemic heart failure with reduced ejection fraction or HFrEF and a left ventricular assist device or LVAD.

FDA provided the feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel-L (Revascor) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation.

In feedback provided to Mesoblast regarding potential pathways to licensure for rexlemestrocel-L, FDA's comments indicated that the presented results may support a reasonable likelihood of clinical benefit of MPCs against mortality in LVAD patients, consistent with the criteria for accelerated approval.

Mesoblast noted that it plans to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation.

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