FDA Approves Mesoblast's Ryoncil for GVHD Treatment

(Reuters) – The U.S. Food and Drug Administration (FDA) approved Mesoblast (NASDAQ:MESO)'s cell therapy for treating graft-versus-host disease (GVHD), a complication arising after stem cell or bone marrow transplants.

The therapy, branded as Ryoncil, is the first mesenchymal stromal cell treatment approved for pediatric patients aged two months and older, specifically targeting those whose GVHD symptoms have not responded to conventional steroid therapy.

While the company has yet to comment on pricing and availability, it’s worth noting that GVHD occurs when donated stem cells attack the recipient's cells, mistaking them for a foreign threat.

Mesenchymal stromal cells, which can differentiate into various cell types, are sourced from the bone marrow of healthy adult donors.

The FDA advises that healthcare providers should closely monitor Ryoncil infusions, discontinuing treatment if any adverse reactions, including shortness of breath, low blood pressure, fever, or rapid breathing, occur.

Notably, last year, the FDA did not approve the therapy due to a need for additional supporting data for marketing approval.