Mesoblast and FDA Align on Key Items for Revascor® Biologic License Application in Ischemic Heart Failure

Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for inflammatory diseases, focusing on severe and life-threatening conditions [4] - The company utilizes a proprietary mesenchymal lineage cell therapy technology platform that releases anti-inflammatory factors to modulate the immune system [4] Recent Developments - Mesoblast announced alignment with the FDA on items required for filing a Biologics License Application (BLA) for Revascor (rexlemestrocel-L) to treat ischemic heart failure with reduced ejection fraction (HFrEF) [1][2] - Following a successful Type B meeting in early 2024, the FDA indicated that the results of the studies could support accelerated approval for Revascor in end-stage HFrEF patients with a left ventricular assist device (LVAD) [2] - The company plans to file for accelerated approval by the end of 2025 for patients with end-stage ischemic HFrEF implanted with an LVAD [3] Product Pipeline - Mesoblast's RYONCIL (remestemcel-L) is the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [5] - The company is developing additional cell therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease [6] - Rexlemestrocel-L is being developed specifically for heart failure and chronic low back pain [6] Intellectual Property and Manufacturing - Mesoblast has a robust global intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection expected to extend through at least 2041 in major markets [7] - The company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8]