Inflammatory drug developer Mesoblast has received good news which clears the way for its remestemcel-L (Ryoncil) drug to go to market.
A panel of the US Oncologic Drugs Advisory Committee (ODAC) of the FDA voted in favour of the view that the “available data support the efficacy” of Ryoncil in cases of transplant rejection.
The condition affects more than 15,000 patients annually with the FDA now set to make a formal decision where it will likely approve patient use of Ryoncil.
Mesoblast chief medical officer Dr Fred Grossman said: “Steroid-refractory acute graft versus host disease (GvHD) is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy.
“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.”
Today the company’s share price, which had slumped on expectations Ryoncil would not meet the approval of the panel, leapt 40 per cent.
Ryoncil is an investigative therapy comprisng culture-expanded mesenchymal stem cells derived from bone marrow.
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