Mesoblast Updates After FDA Meeting on Graft Versus Host Disease Therapy

 

• Meeting held with the US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) to address potency assay and chemistry, manufacturing and controls (CMC) items identified in the complete response letter (CRL) for remestemcel-L in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children

• OTAT indicated that Mesoblast’s approach to address the outstanding CMC items is reasonable

• OTAT indicated that the in vitro immunomodulatory activity Mesoblast intends to measure for potency is a reasonable critical quality attribute (CQA) for the product, and the relevance of this activity to clinical outcomes should be established

• Mesoblast has now generated substantial new data that it believes establish the relevance of the proposed in vitro immunomodulatory activity of remestemcel-L to the in vivo clinical effect of the product in the Phase 3 trial in children with SR-aGVHD, including survival and biomarkers of in vivo activity

• Mesoblast will provide these new data to OTAT, and address other outstanding items as required for the Biologics License Application (BLA) resubmission

https://finance.yahoo.com/news/mesoblast-provides-following-meeting-fda-233800804.html