FDA grants RMAT designation for Mesoblast’s chronic low back pain treatment
pharmafile | February 9, 2023 | News story | Medical Communications |
Mesoblast Ltd, an Australian regenerative medicine company leading in allogeneic cellular medicines for inflammatory diseases, announced that its treatment for chronic low back pain (CLBP) has been granted Regenerative Medicine Advanced Therapies (RMAT) designation by the FDA’s Office of Tissues and Advanced Therapies (OTAT).
Rexlemestrocel-L was tested in a 404-patient, randomised, blinded, placebo-controlled phase 3 trial, where it was combined with hyaluronic acid (HA), which acts as a delivery agent when injecting the drug into the lumbar disc. The data showed that a single injection of rexlemestrocel-L + HA into the lumbar disk significantly reduced pain in comparison with the saline placebo in all patients at both the 12- and 24-month marks.
RMAT designation is awarded in order to encourage the development of regenerative medicine therapies intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, where clinical evidence shows the drug has the potential to address an unmet medical need. This was awarded to rexlemestrocel-L due to the positive data from the phase 3 trial.
Mesoblast Chief Executive Silviu Itescu stated: “We are pleased to receive RMAT designation for our cellular therapy to treat CLBP due to disc degeneration. We look forward to working closely with FDA to efficiently generate the additional data needed to support marketing approval of rexlemestrocel-L for the treatment of this serious and debilitating condition.”
More companies are beginning to supply alternatives to opioid treatments, offering safe, effective, durable and non-addictive therapies to manage or cure chronic diseases.
James Spargo
