Mesoblast Advances rexlemestrocel-L Toward BLA Submission With FDA's Positive Regulatory Feedback On CLBP Treatment

Mesoblast Limited (MESO, MSB.AX), a regenerative medicine developer, has secured constructive guidance from the U.S. Food & Drug Administration regarding a potential Biologics License Application (BLA) for its investigational cell therapy, rexlemestrocel-L, targeting patients suffering from chronic discogenic low back pain (CLBP).

Clinical Trial Data Supports Efficacy Claims

The company’s landmark Phase 3 study, designated MSB-DR003, demonstrated significant outcomes in pain reduction metrics over an extended three-year observation window following a single injection. The trial design specifically measured patient pain intensity changes and tracked corresponding reductions or discontinuation of opioid medications. According to the FDA’s assessment during the Type B regulatory meeting, the active treatment group showed measurably superior pain intensity outcomes compared to the control group. The regulatory agency acknowledged that achieving clinically significant pain reduction at the 12-month primary endpoint provides a credible foundation for establishing product efficacy in the CLBP patient population.

FDA Acknowledges Opioid Reduction as Labeling Asset

Beyond pain relief metrics, the FDA recognized the robust opioid utilization reduction documented in the well-controlled trial. This performance could qualify for inclusion within the Clinical Studies portion of the product’s prescribing information, adding considerable clinical value to the treatment profile and potentially broadening the product’s appeal to healthcare providers seeking alternatives to opioid-dependent pain management.

Regulatory Acceleration Through RMAT Designation

Mesoblast has obtained Regenerative Medicine Advanced Therapy (RMAT) status for rexlemestrocel-L, a designation that encompasses advantages from both the Breakthrough Therapy and Fast Track programs. These benefits include rolling submission capabilities and priority review eligibility once the BLA is formally filed, potentially shortening the traditional approval timeline for this innovative cell-based therapeutic approach.

Market Reaction

Trading activity in MSB.AX reflected modest downward pressure, with shares closing at A$2.57, representing a 2.65% decline from the previous session, despite the positive regulatory communications.