FDA Advisory Committee recommends Ryoncil to treat pediatric patients with steroid-refractory acute graft versus host disease. -MesoBlast Ltd

Mesoblast Limited announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (Ryoncil in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). Mesoblast Chief Medical Officer Dr Fred Grossman said: “Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy. We are very encouraged by today’s outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of Ryoncil for this life-threatening complication of an allogeneic bone marrow transplant.” Ryoncil has been accepted for Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA). If approved by the PDUFA date, Mesoblast plans to launch Ryoncil in the United States in 2020.