Posted by Michael Wonder on 09 Jul 2024
Mesoblast resubmits biologics license application with US FDA for approval of Ryoncil in children with steroid-refractory acute graft versus host disease
8 July 2024 - Mesoblast announced today it has resubmitted its BLA for approval of Ryoncil (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease.
The filing comes after Mesoblast was informed by FDA at the end of March that, following additional consideration, the available clinical data from the Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for treatment of paediatric patients with steroid-refractory acute graft versus host disease.
