Ahead Of Ryoncil’s Advisory Committee, Citizen Petition Opposes Approval For Pediatric GVHD

 
• By Brenda Sandburg
  
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Lawyer asks US FDA to require another trial before licensing Mesoblast’s stem cell therapy for children with SR-aGVHD; Incyte’s Jakafi is only product approved for the indication.

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Investigational drug for pediatric graft-versus-host disease needs more clinical data, citizen petition claims • Source: Shutterstock

Mesoblast Limited's Ryoncil (remestemcel-L) is in on track to be the second product approved for treatment of pediatric steroid-refractory acute graft-versus-host disease in the United States and the first mesenchymal stem cell (MSC) therapy to clear the US Food and Drug Administration. But a citizen petition for an unnamed party argues that the trial data is inadequate and urges the agency to require an additional study before granting licensure.

Scott Lassman, of Lassman Law+Policy, submitted the citizen petition on 20 July, and in response to a query said...

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