Mesoblast Limited, a global leader in allogeneic cellular medicines for inflammatory diseases, has announced the resubmission of its Biologics License Application (BLA) to the United States Food & Drug Administration (FDA) for the approval of Ryoncil®. The company seeks to obtain regulatory approval for the use of Ryoncil® in treating children with steroid-refractory acute graft-versus-host disease (SR-aGVHD), a severe and life-threatening condition that can occur following allogeneic hematopoietic stem cell transplantation.
The resubmission of the BLA follows extensive collaboration between Mesoblast and the FDA to address the agency’s concerns and provide additional data supporting the efficacy and safety of Ryoncil® in pediatric patients with SR-aGVHD. If approved, Ryoncil® could become the first allogeneic cellular medicine available for the treatment of this devastating condition, offering hope to children and their families who currently have limited treatment options.
