First FDA-approved stem cell therapy, Ryoncil, now available. Medicaid coverage coming soon
A significant milestone for the stem cell industry, likely paving the way for future stem cell based therapies.
Mesoblast announced that Ryoncil® (remestemcel-L), a mesenchymal stromal cell (MSC) therapy recently approved by the FDA, is now commercially available in the United States.
Did you know that this was Dr. Arnold Caplan’s product? It was originally branded as Prochymal (remestemcel-L), and he sold this to Mesoblast in 2012. Who knew the late Dr. Caplan’s product would become the first MSC-based therapy approved by the FDA for any indication? Pretty incredible.
Ryoncil® is indicated for pediatric patients aged two months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a condition associated with high mortality rates. The recommended dosing regimen is 2×10⁶ MSC/kg of body weight, administered intravenously twice weekly over a four-week period.
To facilitate patient access, Mesoblast has established a patient support hub called MyMesoblast™, designed to assist patients and healthcare institutions with insurance coverage, financial assistance, and access programs. The therapy can now be ordered through this hub. More details and resources for healthcare providers, patients, and caregivers are available at http://www.ryoncil.com.
Mesoblast stated that it is actively engaging with commercial and government insurers to expedite patient access to treatment. To date, nine commercial payers, representing approximately 37 million covered lives in the U.S., have published favorable medical coverage policies. The company continues to expand its network of commercial payers. Additionally, Mesoblast plans to enter into the National Drug Rebate Agreement with Medicaid and expects enrollment in the program shortly.
“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 devastating disease.”
