The U.S. Food and Drug Administration (FDA) has rejected Mesoblast’s cell therapy for children under 12 years old for treating a certain complication that occurs after a stem cell or bone marrow transplant. The FDA requested more data to support the marketing approval for the company’s lead product, remestemcel-L. This rejection comes as a setback for Mesoblast, especially after its fundraising efforts in recent years.
Mesoblast was seeking FDA approval for a cell therapy to treat graft versus host disease (GvHD) in children, a condition where the recipient is attacked by the donor’s bone marrow or stem cells. Currently, there are no approved therapies for children with this condition whose symptoms do not respond to standard steroid therapy or develop recurrence during treatment. The rejection by the FDA hinders Mesoblast’s plans for launching this potential therapy.
