The United States Food And Drug Administration Grants Orphan-Drug Status To Mesoblast's Revascor For Children With Congenital Heart Disease
The United States Food And Drug Administration Grants Orphan-Drug Status To Mesoblast's Revascor For Children With Congenital Heart Disease
美國食品藥品監督管理局授予Mesoblast針對先天性心臟病患兒的Revascor的孤兒藥地位
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.
治療炎性疾病的異基因細胞藥物的全球領導者Mesoblast Limited今天宣佈，美國食品藥品監督管理局（FDA）在提交了針對左心發育不全綜合症（HLHS）（一種可能危及生命的先天性心臟病）兒童的隨機對照試驗結果後，已授予其異體細胞療法Revascor（rexlemestrocel-L）孤兒藥稱號（ODD）。這是繼美國食品藥品管理局上個月批准的罕見兒科疾病認證（RPDD）之後發生的。