Mesoblast: FDA Sets Pre-License Inspection of Remestemcel-L Manufacturing

 

• Biologics License Application (BLA) Resubmission for Pediatric Acute Graft-Versus-Host Disease (SR-aGVHD) Currently Being Reviewed
• PDUFA Goal Date August 2, 2023
• If Approved, Remestemcel-L will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Therapy for Children Under 12 Years Old with SR-aGVHD

 Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that, as part of the ongoing review of the BLA for remestemcel-L in the treatment of children with SR-aGVHD, the United States Food and Drug Administration (FDA) has scheduled a Pre-License Inspection (PLI) of Mesoblast’s cell therapy manufacturing operations at Lonza Bioscience in Singapore.

On March 7, 2023, the FDA accepted the Company’s resubmission of the BLA for remestemcel-L and set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023.

Remestemcel-L has FDA Fast Track designation, a process to facilitate the development and expedited review of therapies for serious conditions that fill unmet medical needs, and Priority Review designation, which is given to drugs that treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments. Survival outcomes have not improved over the past two decades for children or adults with the most severe forms of SR-aGVHD.^1-3 The lack of any approved treatments for children under 12 means that there is an urgent need for a therapy that improves the dismal survival outcomes in children.

https://www.biospace.com/article/releases/fda-schedules-pre-license-inspection-of-remestemcel-l-manufacturing/