Mesoblast Ltd makes rolling submission to FDA for remestemcel-L in children with steroid-refractory acute graft versus host disease.

Mesoblast Limited announced that the FDA has agreed that Mesoblast can submit on a rolling basis a Biologics License Application (BLA) for its allogeneic cellular medicine remestemcel-L in children with steroid-refractory acute Graft Versus Host Disease (SR-aGVHD). Mesoblast will submit each module of the BLA to the FDA on a rolling basis as it is completed. The rolling process will provide opportunity for ongoing and frequent communication, and during this process the Company expects it will be able to adequately address any substantial matters raised by the FDA.

Mesoblast has previously received Fast Track designation from the FDA for remestemcel-L in SRaGVHD and is eligible for priority review once the BLA filing is completed and accepted by the FDA. Mesoblast expects to submit the first module shortly.

About Steroid-refractory Acute Graft Versus Host Disease- SR-aGVHD is a life-threatening complication of a bone marrow transplant in patients primarily being treated for blood cancers. There are more than 30,000 allogeneic bone marrow transplants performed globally, with a total of over 20,000 in the United States and the EU5 annually. Approximately 20% occur in children. Currently, there are no approved products for SR-aGVHD in children outside Japan, where Mesoblast licensee JCR Pharmaceuticals markets Temcell1 HS Inj. for both children and adults with aGVHD.