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The health regulator required more data to support marketing approval for the company’s lead product remestemcel-L, Mesoblast said in a statement.
The rejection deals a blow to Mesoblast’s hopes for a potential launch of the therapy, especially after its fundraising efforts over the last two years.
The drug developer was seeking the FDA’s approval for a cell therapy to treat children with a type of graft versus host disease (GvHD), whose symptoms did not respond to standard steroid therapy or developed recurrence while continuing treatment.
There are no approved therapies in children for the condition in which the donor bone marrow or stem cells attack the recipient.
