Mesoblast Submits Clinical Efficacy and Safety Data to FDA in Rolling Biologics License Application for Remestemcel-l [Yahoo! Finance News]
Mesoblast Limited - American Depositary Shares (MESO)
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Source: Yahoo! Finance News
Mesoblast Limited : MESO The clinical submission included analyses of 309 children with SR-aGVHD who have received remestemcel-L across three separate studies. In addition, Mesoblast provided new data in control pediatric subjects from the contemporaneous database of the Mount Sinai Acute GVHD International Consortium MAGIC) to provide an unbiased and independent estimate of response rates and outcomes in matched pediatric control patients treated with institutional standard of care. The results of the comparative analysis between Mesoblast's open-label Phase 3 study and contemporaneous controls receiving institutional standard of care demonstrate the effectiveness of remestemcel-L in this patient population, with particular efficacy and survival benefit in patients with the most severe forms of aGVHD. These conclusions are supported by prior results from an Expanded Access Program in 241 children where remestemcel-L was used as salvage therapy after failure of steroids and other agen
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