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# Mesoblast Remestemcel-L BLA Resubmitted
- URL: https://www.fdaweb.com/mesoblast-remestemcel-l-bla-resubmitted/
- Published: 2023-03-08T12:00:00.000Z
- Updated: 2026-09-14T18:18:28.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153928

FDA has accepted a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). The agency has set a user fee review action target date of 8/2.

In 2020, FDA issued a complete response letter on the original BLA and recommended that the company conduct at least one additional randomized, controlled study in adults or children to provide further evidence of the therapy’s effectiveness. Additionally, FDA identified a need for further scientific rationale to “demonstrate the relationship of potency measurements to the product’s biologic activity,” the company said at the time. “Assays measuring the potency of remestemcel-L will continue to be refined to provide further scientific rationale for its use in severe inflammatory diseases with high mortality risk,” it said.

Prior to the complete response action, FDA’s Oncologic Drugs Advisory Committee voted nine to one in favor of approving the therapy. The positive vote negated FDA briefing documents that challenged the biologic’s effectiveness and durability of patient responses ([see earlier story](https://www.fdaweb.com/fda-challenges-remestemcell-l-data/)).

Mesoblast says the resubmission contains the following new information:

- new long-term survival data through at least four years for children enrolled in a Phase 3 trial,
- new outcome data following remestemcel-L use in high-risk disease activity and on survival using propensity-matching of children in the Phase 3 trial and controls stratified by validated biomarkers,
- new analyses of prospectively obtained data related to the validated potency assay,
- new analyses of clinical data obtained prospectively on manufacturing changes made during product development,
- new data on the validated potency assay, and
- a new specification for release of commercial product