Mesoblast Resubmits Application in Graft-Versus-Host Disease

  Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil^® (remestemcel-L) in the treatment of children with SR-aGVHD.

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 pediatric patients with SR-aGVHD. As a result, the filing addresses remaining CMC (Chemistry, Manufacturing, and Control) items.

https://www.biospace.com/article/releases/mesoblast-resubmits-biologics-license-application-bla-with-united-states-food-and-drug-administration-fda-for-approval-of-ryoncil-in-children-with-steroid-refractory-acute-graft-versus-host-disease-sr-agvhd-/