Leading allogeneic cellular medicines developer, Mesoblast Limited (ASX: MSB) recently submitted its completed Biologics License Application (BLA) 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, marking a major corporate milestone for Mesoblast.
Notably, RYONCIL has been used in 309 children with SR-aGVHD across three separate studies and along with this, it was also used as salvage therapy in an expanded access program in 241 children with SR-aGVHD (80% Grade C/D) who failed institutional standard of care.
If the product gets approval from FDA, it is expected to launch in the US in 2020.
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