- FDA and Mesoblast (MESO, Financial) align on key requirements for Revascor® BLA filing.
- Revascor® targets ischemic heart failure with reduced ejection fraction (HFrEF).
- Accelerated approval filing anticipated by the end of 2025.
Mesoblast (NASDAQ:MESO), a leader in allogeneic cellular medicines, has taken a crucial step forward in the regulatory process for its Revascor® (rexlemestrocel-L) treatment. The company has aligned with the United States Food and Drug Administration (FDA) on the key requirements needed for filing a Biologics License Application (BLA) for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF) and inflammation.
This development follows a successful Type B meeting under the Regenerative Medicine Advanced Therapy (RMAT) designation. During the meeting, the FDA indicated that Mesoblast's submitted studies could support an accelerated approval. Mesoblast subsequently met with the FDA on June 3, 2025, to finalize alignment on crucial aspects, including chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and the proposed design and primary endpoint for the confirmatory trial post-approval.
With these alignments in place, Mesoblast plans to submit a filing for accelerated approval by the end of 2025. The focus is on treating patients with end-stage ischemic HFrEF who have been implanted with a left ventricular assist device (LVAD). This effort underscores Mesoblast's commitment to advancing innovative treatments for severe inflammatory conditions and improving patient outcomes.
