Mesoblast has resubmitted a biologic license application to the US Food and Drug Administration for the approval of Ryoncil to treat children with steroid-refractory acute graft versus host disease.

The decision for the resubmission was taken after the FDA communicated in March that the clinical data from the Phase 3 study, MSB-GVHD001, appeared sufficient to support the proposed biologic license application.

"We have worked closely with the agency and thank them for their ongoing guidance, facilitating the potential approval of Ryoncil and addressing the urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD," said Mesoblast CEO Silviu Itescu.

The review period for the resubmitted biologic license application is expected to range between two to six months from the date of receipt.