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Will RYONCIL® receive EMA approval for pediatric GVHD by end of 2025?
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Resolution / Starting Odds
Yes • 50%
No • 50%
European Medicines Agency (EMA) announcements and press releases
Story
FDA Approves RYONCIL® for Pediatric Graft-Versus-Host Disease Treatment on December 18, 2024, as First MSC Therapy
Dec 18, 2024, 10:23 PM
The U.S. Food and Drug Administration (FDA) has approved Remestemcel-L, marketed as RYONCIL®, for the treatment of pediatric steroid-refractory acute graft-versus-host disease (GVHD). This approval, announced on December 18, 2024, allows the use of this allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy for patients aged two months and older who are experiencing this serious complication following stem cell or bone marrow transplants. Mesoblast, the company behind the therapy, has now achieved a milestone as RYONCIL® becomes the first MSC therapy approved in the United States, a significant advancement in the treatment options available for this vulnerable patient population.
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Yes • 50%
No • 50%
Yes • 50%
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Yes • 50%
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Accelerated Approval • 25%
Full Approval • 25%
Conditional Approval • 25%
No Approval • 25%
FDA only • 25%
EMA only • 25%
Both FDA and EMA • 25%
Neither • 25%