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Meetings Held With FDA Support Mesoblast’s Planned Regulatory Filing for Commercialization of Remestemcel-L in Acute GVHD | ||
By: Nasdaq / GlobeNewswire - 13 Dec 2018 | Back to overview list |
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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 currently no approved products in the United States for aGVHD. Mesoblast owns all commercial rights to remestemcel-L for all territories excluding Japan. In Japan, Mesoblast’s licensee, JCR Pharmaceuticals Co. Ltd., is marketing TEMCELL®1 HS. Inj. for the treatment of aGVHD in children and adults. Mesoblast receives royalty income on sales of TEMCELL in Japan as well as milestone payments. In North America and EU5 countries, Mesoblast estimates that the addressable market opportunity is in excess of $US700 million per annum. About Mesoblast 1. TEMCELL® HS Inj. is the registered trademark of JCR Pharmaceuticals Co. Ltd. Forward-Looking Statements For further information, please contact: Julie Meldrum Schond Greenway |
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Copyright 2018 Nasdaq / GlobeNewswire | Back to overview list |