Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure

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[{"type":"image","alt":"Mesoblast Limited","displaySize":"","headline":null,"caption":"Mesoblast Limited","className":"","disableSlideshowImg":false,"size":{"original":{"width":289,"height":38,"url":"https://media.zenfs.com/en/globenewswire.com/3a26a2f63129fae6650ef7618b48c2df"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/qVvwFFYM1KHQf5WBcCEDQw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTU1O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/3a26a2f63129fae6650ef7618b48c2df","width":289,"height":38}},"lazy":false},{"type":"text","content":"NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation.","length":455,"tagName":"p"},{"type":"text","content":"Mesoblast filed a request for a Type B meeting during the last quarter, in line with previous guidance, and expects to have the meeting during this quarter. The meeting will be held under Mesoblast’s Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR.","length":272,"tagName":"p"},{"type":"text","content":"In a Type B meeting last year, FDA provided guidance to Mesoblast that the company was eligible to file for accelerated approval of REVASCOR in patients with end-stage HFrEF based on the totality of data across two randomized controlled trials. FDA also guided that a single confirmatory trial in class II/III patients with ischemic HFrEF and inflammation will need to be completed after any accelerated approval is obtained.","length":425,"tagName":"p"},{"type":"text","content":"The key objectives of the meeting are to obtain FDA feedback on relevant chemistry, manufacturing & controls (CMC), alignment on potency assays for commercial product release, and Mesoblast’s proposed design and primary endpoint for the confirmatory trial.","length":260,"tagName":"p"},{"type":"text","content":"About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from...

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