Posted by Michael Wonder on 08 Mar 2023
FDA accepts Mesoblast’s resubmission of the biologic license application for remestemcel-L in children with steroid-refractory acute graft versus host disease as a complete response
7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and the first therapy for children under 12 years old with steroid-refractory acute graft versus host disease.
Mesoblast today announced that the US FDA Office of Therapeutic Products has accepted the company’s biologics license application resubmission for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease.
The FDA considers the resubmission to be a complete response and has set a PDUFA goal date of 2 August 2023.
