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
美国食品药品监督管理局授予Mesoblast针对先天性心脏病患儿的Revascor的孤儿药地位
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.
治疗炎性疾病的异基因细胞药物的全球领导者Mesoblast Limited今天宣布，美国食品药品监督管理局（FDA）在提交了针对左心发育不全综合症（HLHS）（一种可能危及生命的先天性心脏病）儿童的随机对照试验结果后，已授予其异体细胞疗法Revascor（rexlemestrocel-L）孤儿药称号（ODD）。这是继美国食品药品管理局上个月批准的罕见儿科疾病认证（RPDD）之后发生的。