The United States Food And Drug Administration Grants Orphan-Drug Status To Mesoblast's Revascor For Children With Congenital Heart Disease

Benzinga ·  Feb 15 02:54

Mesoblast Limited global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition. This follows the Rare Pediatric Disease Designation (RPDD) granted by FDA last month.

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