Mesoblast (ASX:MSB), a leader in allogeneic cellular medicines, reported that the US Food & Drug Administration has acknowledged that data from the company's first Phase 3 trial of rexlemestrocel-L for chronic discogenic low back pain favour the therapy in reducing pain intensity.
The FDA confirmed that the 12-month reduction in pain observed in the trial supports the product’s efficacy and noted that robust evidence of opioid reduction could be included in future product labeling.
Rexlemestrocel-L, an allogeneic stromal cell therapy, is currently being evaluated in a second Phase 3 trial enrolling 300 patients across 40 US sites.
CLBP, a leading cause of disability and contributor to opioid use in the US, affects millions of adults and is associated with significant quality-of-life limitations.