Mesoblast Seeks FDA Nod for Pediatric GVHD Treatment

Mesoblast (MESO) has released an update.

Mesoblast Limited has resubmitted a Biologics License Application (BLA) to the FDA for Ryoncil®, aiming to treat children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD). The resubmission, buoyed by promising Phase 3 study results demonstrating significant survival benefits, could meet an urgent need for effective treatment in this patient group, as current survival outcomes are poor and no FDA-approved treatments exist for children under 12 with SR-aGVHD. With Fast Track and Priority Review designations, Ryoncil® could be approved within a 2 to 6-month review period upon acceptance of the BLA.

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