Posted by Michael Wonder on 05 Feb 2020
Mesoblast submits completed biologics license application for Ryoncil to US FDA
3 February 2020 - Mesoblast today announced that it has submitted its completed niologics license application to the US FDA for Ryoncil (remestemcel-L), its lead allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease.
Mesoblast filed the final module of the rolling submission, covering quality control and manufacturing, with the FDA on January 31.
The Company has requested priority review of the application by the FDA under the product candidate’s existing fast track designation for steroid-refractory acute graft versus host disease. If approved, Ryoncil is expected to be launched in the US in 2020.
