Mesoblast Resubmits BLA for Remestemcel-L
More than two years after receiving an FDA rejection, Mesoblast has resubmitted its biologics license application (BLA) for remestemcel-L, a treatment for children afflicted with steroid-refractory acute graft vs. host disease (SR-aGVHD).
The Melbourne, Australia-based drugmaker said the updated BLA features “substantial” new information as required by the FDA’s September 2020 complete response letter, which expressed concerns over assays the company used to measure the stem cell therapy’s potency.
The application includes new data analyses showing that the “the validated potency assay … measures a key product attribute which reflects the primary mechanism of action … and predicts overall survival outcomes,” the company said.
At present, there are no FDA-approved treatments for children under age 12 afflicted with SR-aGVHD.
February 7, 2023
