US FDA Agrees to the Selection of Mesoblast Limited's Ryoncil as the Commercial Name for its Lead Allogeneic Cell Therapy Remestemcel-L in the Treatment of Pediatric Steroid-Refractory Acute Graft Versus Host Disease
January 15, 2020 at 06:00 am EST
Mesoblast Limited reported that the United States Food and Drug Administration (US FDA) has agreed to the selection of Ryoncil™ as the commercial name for its lead allogeneic cell therapy remestemcel-L in the treatment of pediatric steroid-refractory acute graft versus host disease (aGVHD). Commercial plans for Ryoncil™ were presented at the 2020 Biotech Showcase being held this week in San Francisco, CA. The final module of the rolling Biologics License Application for Ryoncil™ will be filed with the FDA in January, following which the Company will request a priority FDA review of the BLA under the product candidate’s existing Fast Track designation. If approved, Ryoncil™ is planned to be launched in the US in 2020.