Meetings Held With FDA Support Mesoblast’s Planned Regulatory Filing for Commercialization of Remestemcel-L in Acute GVHD
Mesoblast Limited - American Depositary Shares (MESO)
US:NASDAQ Investor Relations:
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Source: GlobeNewswire
NEW YORK and MELBOURNE, Australia, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that recent meetings held with the United States Food and Drug Administration (FDA) support its planned regulatory filing for commercialization of remestemcel-L in pediatric patients with steroid refractory acute graft versus host disease (aGVHD). Mesoblast gained agreement from the FDA on the proposed chemistry and manufacturing for commercialization. The FDA also provided guidance on the presentation of data from the completed 55-patient Phase 3 trial and the 241-patient Expanded Access Program to be included in the filing for the proposed indication. In the Phase 3 trial, Mesoblast met the pre-specified primary endpoint of improved Day 28 overall response and improved responder survival through Day 180. Mesoblast plans to initiate the submission of the BLA with the FDA in early 2019 for the use of remestemcel-L in treating aGVHD in children. There are cu
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