Mesoblast files for orphan drug and pediatric rare disease designations for rexlemestrocel-l as treatment for severe congenital heart disease

New york, nov. 26, 2023 (globe newswire) -- mesoblast limited (nasdaq:meso; asx:msb), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has filed for orphan drug designation (odd) and rare pediatric disease designation (rpdd) with the united states food and drug administration (fda) for its allogeneic cell therapy revascor® (rexlemestrocel-l) in the treatment of the congenital heart disease hypoplastic left heart syndrome (hlhs). the filings were based on results from a blinded, randomized, controlled prospective trial of revascor conducted at a single center in the us in 19 children with hlhs and accepted for publication in an upcoming issue of the peer reviewed the journal of thoracic and cardiovascular surgery open (jtcvs open). 1
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