Mesoblast has gained US Food and Drug Administration (FDA) approval for its mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), to treat steroid-refractory acute graft versus host disease (SR-aGvHD) in paediatric patients aged a minimum of two months and up to adolescents and teenagers.
It is the only MSC therapy approved in the US for any indication.
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Ryoncil is part of a development programme for inflammatory diseases such as SR-aGvHD in adults, and biologic-resistant inflammatory bowel disease.
Other therapies, such as rexlemestrocel-L, are being developed for conditions such as chronic lower back pain and heart failure. The company has established commercial partnerships for these therapies in China, Japan and Europe.
Mesoblast chief executive Dr Silviu Itescu stated: “We are very pleased that the FDA has granted approval of Ryoncil and proud of the company’s commitment to the GVHD community in bringing this important new treatment to children and families with no other acceptable options.
“With RYONCIL’s approval by the FDA, Mesoblast has demonstrated the ability to bring the first MSC product to market. We will continue to work closely with the FDA to obtain approval of our other late-stage products, including REVASCOR for cardiovascular diseases and rexlemestrocel-L for inflammatory pain indications, as well as expanding the indications for RYONCIL in both children and adults with inflammatory conditions.”
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By GlobalDataThe mesenchymal lineage cell therapy technology platform of the company is designed to respond to severe inflammation with the release of anti-inflammatory factors. These factors counter and modulate multiple effector immune system arms, leading to a reduction in the damaging inflammatory process.
In the US, the therapy will be available at hospitals and transplant centres.
10,000 individuals in the US undergo an allogeneic bone marrow transplant annually, of whom 1,500 are paediatric patients.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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