Mesoblast (NASDAQ:MESO; ASX:MSB) submitted its completed biologics license application (BLA) to the FDA for Ryoncil, its lead allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
The company has requested priority review of the BLA under the drug candidate’s existing fast track designation for SR-aGVHD. If approved, Ryoncil is expected to be launched in the U.S. in 2020.
Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing, Mesoblast CEO, Dr. Silviu Itescu, said in a statement.
Ryoncil has been used in 309 children with SR-aGVHD across three separate studies. There are currently no FDA-approved treatments in the U.S. for children under the age of 12 with SR-aGVHD.
