
FDA panel votes 9-1 in favour of approval for Mesoblast’s Ryoncil in paediatric steroid-refractory acute graft versus host disease
pharmafile | August 14, 2020 | News story | Medical Communications, Sales and Marketing | FDA, Mesoblast, Ryoncil, pharma
It’s good news for Mesoblast as an expert FDA panel gave a glowing recommendation for the approval in the US of the company’s Ryoncil (remestemcel-L) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
The US regulator’s Oncologic Drugs Advisory Committee (ODAC) voted nine to one in favour of approving the therapy for routine use in the country – a strong show of support from experts in the field of the therapy’s safety and efficacy in this indication.
However, while the ruling will give clout to the success of Ryoncil in its regulatory review, the FDA is not beholden to the decision and may ultimately reach another judgement. The good news for Mesoblast is that the US regulator historically tends to side with its advisory committees when it comes to a final decision.
“Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy,” Mesoblast Chief Medical Officer Dr Fred Grossman said of the news. “We are very encouraged by today’s outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of Ryoncil for this life-threatening complication of an allogeneic bone marrow transplant.”
Matt Fellows
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