Ryoncil FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 31, 2024.
FDA Approved: Yes (First approved December 18, 2024)
Brand name: Ryoncil
Generic name: remestemcel-L-rknd
Dosage form: Cell Suspension for Intravenous Infusion
Company: Mesoblast Limited
Treatment for: Graft Versus Host Disease
Ryoncil (remestemcel-L-rknd) is an allogeneic bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.
- Steroid-refractory acute graft-versus-host disease (SR-aGVHD) is a serious and life-threatening condition that can occur as a complication of allogeneic hematopoietic stem cell transplantation. Acute GvHD occurs when alloreactive donor-derived T cells within the donated tissue trigger an immunological response.
- Ryoncil is a mesenchymal stromal cell (MSC) therapy derived from the bone marrow of healthy adult human donors. MSCs are a type of cell that can have various roles in the body and can differentiate into multiple other types of cells.
- Ryoncil is thought to work in the treatment of SR-aGVHD by immunomodulatory effects, including inhibition of T cell activation and secretion of pro-inflammatory cytokines.
- FDA approval of Ryoncil was based on results of the MSB-GVHD001 study of 54 pediatric patients with SR-GvHD Grade B to D. Sixteen study participants (30%) had a complete response to treatment 28 days after receiving Ryoncil, while 22 study participants (41%) had a partial response.
- Ryoncil is administered by intravenous infusion twice per week (at least 3 days apart) for 4 consecutive weeks. Further treatment can be administered depending on the response at Day 28.
- Warnings and precautions associated with Ryoncil include hypersensitivity and acute Infusion reactions, and transmission of infectious agents.
- Common adverse reactions (incidence ≥20%) include viral infectious disorders, bacterial infectious disorders, infections (pathogen unspecified), pyrexia, hemorrhage, edema, abdominal pain and hypertension.
Development timeline for Ryoncil
Further information
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