US FDA accepts Biologics Licence application for remestemcel-L (Ryoncil™) for the treatment of children with steroid-refractory acute graft versus host disease (SR- aGVHD)
Remestemcel-L is an investigational allogeneic cell therapy, comprising culture- expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to have immunomodulatory properties to counteract inflammatory processes implicated in SR- aGVHD.
Source:
Biospace Inc.
SPS commentary:
Remestemcel-L, an advanced therapy medicinal product, is currently in Phase III development in the UK/EU.