Mesoblast (ASX:MSB) has announced that its FDA-approved Ryoncil (remestemcel-L) mesenchymal stromal cell (MSC) therapy is now available for purchase in the US.
Ryoncil is approved for the treatment of paediatric patients two months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a condition with high mortality rates.
Mesoblast said it had established a patient access hub termed MyMesoblast, where Ryoncil is now available for ordering. It said it has been engaging with commercial and government insurers to expedite patient access to therapy. Nine commercial payers have published favourable medical policies representing approximately 37 million covered lives in the US. The company said it will enter into the National Drug Rebate Agreement with Medicaid and expects to enrol in the program.
“The commercial availability of RYONCIL is a significant milestone in our mission to bring innovative cellular medicines to patients in need,” said Dr Silviu Itescu, CEO of Mesoblast. “We have made RYONCIL available three months after receiving FDA approval, a significant commercial achievement and a reflection of our team and partners who are driven by the overwhelming desire to help children and their families faced with this devasting disease.”