The US Food and Drug Administration (FDA) has granted a Fast Track designation to regenerative medicine company, Mesoblast Ltd
(ASX:MSB), for the use of its cell therapy (MSC-100-IV).
Mesoblast’s cell therapy aims to improve the overall response rate in children suffering from a condition called steroid refractory acute Graft Versus Host Disease.
Graft Versus Host Disease is a condition that usually occurs after transplant operations, when donated bone marrow or stem cells attack the recipient. Patients are usually treated with steroids but, but one particular variation of the disease is resistant to steroids, which results in high mortality rates.
Mesoblast says the Fast Track designation can potentially shorten the time to FDA approval – from 10 months to 6 months.
This morning, shares in Mesoblast traded 4.8% higher at $1.86.
