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Mesoblast Finally Gets FDA Nod For Ryoncil

 
• By Alaric DeArment

The cell therapy won approval for pediatric steroid-refractory acute graft versus host disease after two complete response letters over the last four years.

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• Source: Shutterstock

Mesoblast plans to immediately start onboarding transplant centers following the US Food and Drug Administration approval of its allogeneic cell therapy Ryoncil (remestemcel-L) for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD), after it was the subject of two complete response letters (CRL) from the agency.

The FDA approved Ryoncil on 18 December – ahead of the 7 January 2025 user fee date – as the first mesenchymal stromal cell (MSC) therapy and the first approved treatment for SR-aGVHD in

Key Takeaways
  • The FDA approved Mesoblast’s mesenchymal stromal cell therapy Ryoncil as the first in its class and the first for young children with steroid-refractory acute GVHD.
  • The company plans to rapidly commercialize the therapy at the top transplant centers that treat 77% of patients, but it is still working on pricing

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