FDA approved Mesoblast's Ryoncil for pediatric steroid-refractory acute GVHD in 2024
The agency cleared remestemcel-L-rknd for children 2 months and older with steroid-refractory acute graft versus host disease.
The FDA approved remestemcel-L-rknd, marketed as Ryoncil by Mesoblast, Inc., on December 18, 2024. The agency approved this allogeneic bone marrow-derived mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.1
Remestemcel-L-rknd works as an MSC-based cell therapy derived from donor bone marrow rather than the patient's own cells. The approval addresses a pediatric population with a serious complication that can arise after allogeneic stem cell transplants, when graft versus host disease does not respond to standard steroid treatment.
The FDA's announcement did not include additional details on clinical trial data, dosing regimens, or label specifics beyond the approved indication and age range. Readers seeking further information on efficacy endpoints, safety data, or prescribing details should consult the full FDA label and any associated clinical trial records for Ryoncil.
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