Mesoblast Submits Data To FDA IND File In Response To Items In CRL To Remestemcel-L BLA For SR-aGVHD

(RTTNews) - Mesoblast Limited (MESO, MSB.AX) said that it has submitted to the U.S. Food and Drug Administration substantial new information on clinical and potency assay items identified in the Complete Response Letter received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease or SR-aGVHD.

Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.

Acute GVHD occurs in about 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, including about 20% in pediatric patients.

SR-aGVHD is associated with mortality as high as 90% and significant extended hospital stay costs. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.