Mesoblast Available Phase 3 Data Support BLA Submission in Graft Versus Host Disease

  Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

“We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SR-aGVHD,” said Mesoblast CEO Dr. Silviu Itescu.

Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining product characterization issues.

https://www.biospace.com/article/releases/united-states-food-and-drug-administration-notifies-mesoblast-that-available-clinical-data-from-phase-3-trial-appear-sufficient-to-support-bla-submission-for-remestemcel-l-in-children-with-steroid-refractory-acute-graft-versus-host-disease/