Mesoblast Limited Resubmits Biologics License Application to FDA; New Data Shows Long-Term Survival Outcomes

Mesoblast Limited, (Nasdaq: MESO; ASX:), a global leader in allogeneic cellular medicines for inflammatory diseases has resubmitted its Biologics License Application (BLA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Remestemcel-L has the potential to be the first allogeneic off-the-shelf cellular medicine to be approved in the United States, and the first therapy for children under 12 years old with SR-aGVHD.

Highlights

• Mesoblast’s resubmission contains substantial new information including improving inflammatory biomarkers and survival in children at the highest risk of mortality.
• The company’s BLA resubmission will have a review period up to six months from filing with the FDA.
• Remestemcel-L has been granted Fast Track designation and Priority Review designation by the FDA. Both designations are designed to facilitate the development and expedited review of therapies for serious conditions that fill unmet medical needs.

SR-aGVHD is a life-threatening complication of an allogeneic bone marrow transplant following treatment for blood cancers and other conditions. Survival outcomes have not improved over the past two decades for the most severe forms of SR-aGVHD, highlighting the urgent need for an effective therapy.