Trial Profile
A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Culture-Expanded Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 24 Dec 2024
Price :
$35
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At a glance
- Drugs Remestemcel-L (Primary)
- Indications Graft-versus-host disease
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Mesoblast
- 18 Dec 2024 According to a Mesoblast media release, the Food and Drug Administration (FDA) approved Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the United States. RYONCIL is the only MSC therapy approved in the U.S. for any indication, and the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents and teenagers.
- 23 Jul 2024 According to a Mesoblast media release, the United States Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) resubmission for Ryoncil (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD), under priority review. FDA considers the resubmission to be a complete response and Mesoblast anticipates a decision on or before the FDAs Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025.
- 09 Jul 2024 According to a Mesoblast media release, company has resubmitted its BLA for approval of Ryoncil (remestemcel-L) in the treatment of children with SR-aGVHD. The BLA resubmission upon acceptance is expected to have a review period of between two and six months from receipt.