US FDA Questions Adequacy Of Mesoblast’s Remestemcel-L Single-Arm Study For Pediatric GVHD
In advisory committee briefing documents, agency also says critical quality attributes of the graft-versus-host disease treatment do not show a relationship with clinical potency and may not ensure control of clinical effectiveness of individual drug product lots.
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Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns"
Oncologic Drugs Advisory Committee votes 8-2 that data support efficacy of the product, which could be the first mesenchymal stem cell product to clear the agency. FDA's concerns include reliance on a pivotal Phase III single-arm study.
Lawyer asks US FDA to require another trial before licensing Mesoblast’s stem cell therapy for children with SR-aGVHD; Incyte’s Jakafi is only product approved for the indication.
The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.