FDA Agrees to Rolling Review of Mesoblast's Biologics License Application for Its Cell Therapy in Children With Steroid-Refractory Acute Graft Versus Host Disease
NEW YORK and MELBOURNE, Australia, April 16, 2019 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) global leader in cellular medicines for inflammatory diseases, announced today that the United States Food and Drug Administration (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 SR-aGVHD 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 TEMCELL®1 HS Inj. for both children and adults with aGVHD.
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) has leveraged its proprietary immunomodulatory cellular technology platform to establish a broad portfolio of late-stage allogeneic (off-the-shelf) product candidates with three product candidates in Phase 3 trials - acute graft versus host disease, chronic heart failure and chronic low back pain due to degenerative disc disease. Mesoblast has developed proprietary cell manufacturing processes, including use of immunoselection, master cell banks, industrialized culture expansion, potency assays, and stringent lot release criteria, to enable large-scale production of cellular therapies that can be used with off-the-shelf logistics from a single donor to thousands of unrelated recipients. Mesoblast has facilities in Melbourne, New York, Singapore and Texas and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq ( MESO ). www.mesoblast.com
1. TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.
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Source: Mesoblast Limited