Posted by Michael Wonder on 30 May 2019
Mesoblast initiates rolling submission of biologics license application to U.S. FDA for remestemcel-L in the treatment of acute graft versus host disease
30 May 2019 - Mesoblast today announced that it has filed the first component of a rolling submission for a biologics license application to the U.S. FDA for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease, a life-threatening complication of an allogeneic bone marrow transplant.
Remestemcel-L has received fast track designation for acute graft versus host disease and under this designation Mesoblast intends to request a priority review once its filing is completed and accepted by the FDA.
In Mesoblast’s Phase 3 trial of 55 children with aGVHD - 89% of whom had Grade C/D disease - treatment with remestemcel-L resulted in a six-month survival of 69%.
