The USFDA has granted orphan drug designation to Pluristem Therapeutics' PLacental eXpanded (PLX) cells to treat aplastic anemia.
The failure of hematopoietic stem cells (HSCs) present in the bone marrow to produce red blood cells, white blood cells and platelets, results in aplastic anemia.
Pluristem chairman and CEO Zami Aberman said, "Receiving orphan drug designation for aplastic anemia is an important event for Pluristem as it open pathways for using our PLX cells for additional indications in the field of hematology."
In August 2011, Pluristem's PLX cells received FDA orphan drug status for the treatment of Buerger's disease.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/pluristem-aplastic-anemia-therapy-wins-fda-orphan-drug-status-220213