FDA Accepts Mesoblast’s BLA Resubmission for Graft Versus Host Disease
The FDA has accepted Mesoblast’s biologics license application (BLA) resubmission for remestemcel-L in treating children with steroid-refractory acute graft versus host disease, a life-threatening complication of an allogeneic bone marrow transplant.
The FDA declined to approve the company’s initial BLA in October 2020 and called for “at least one additional randomized, controlled study in adults and/or children to provide further evidence” of the drug’s efficacy. The resubmitted BLA contains new data regarding the drug’s potency as well as long-term survival data for children who were enrolled in a phase 3 study for at least four years.
There are currently no approved treatments for children under age 12 with steroid-refractory acute graft versus host disease.
The FDA’s target decision date on the resubmission is Aug. 2.