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.
Mesoblast CEO Silviu Itescu emphasised that rexlemestrocel-L "could offer a powerful solution for managing chronic inflammatory back pain while contributing to opioid reduction or cessation."
The therapy has also received FDA Regenerative Medicine Advanced Therapy designation, providing potential eligibility for expedited review.
At the time of reporting, Mesoblast's share price was $2.60.