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FDA Gives Nod To Rolling Review Of Company's License Application For GvHD Therapy.

NEW YORK, N.Y., April 16, 2019 -- Mesoblast Limited (NASDAQ:MESO) announced that the FDA has agreed that Australian stem cell company 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, the company said.

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."

SR-aGVHD is a life-threatening complication of a bone marrow transplant in patients primarily being treated for blood cancers.

More than 30,000 allogeneic bone marrow transplants are performed annually worldwide, including 20,000 in the U.S. and the EUS. Twenty percent occur in children.

No approved products for SR-aGVHD in children exist outside of Japan, where Mesoblast licensee JCR Pharmaceuticals markets TEM-CELL1 HS Inj. for both children and adults with aGVHD.


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Title Annotation:Biologic Licensing
Publication:Stem Cell Lab World
Date:Apr 29, 2019
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