Mesoblast Limited (MESO,MSB.AX) announced that it has received feedback from the U.S. Food & Drug Administration (FDA) regarding the potential filing of a Biologics License Application (BLA) for its allogeneic cell therapy product, rexlemestrocel-L, in patients with chronic discogenic low back pain (CLBP). This update follows the FDA's Type B meeting review of data from Mesoblast's first randomized controlled Phase 3 trial (MSB-DR003), which evaluated pain reduction and the relationship to decreased or eliminated opioid use for up to three years after a single administration of rexlemestrocel-L.
Mesoblast is seeking FDA approval for rexlemestrocel-L based on demonstrated reduction in CLBP through 12 months. In comparing outcomes between rexlemestrocel-L and placebo in the MSB-DR003 trial, the FDA acknowledged that pain intensity outcomes favored the active treatment arm. The agency further confirmed that a clinically meaningful reduction in pain intensity at 12 months could support product efficacy. Additionally, the FDA noted that the robust results on opioid reduction from at least one adequate and well-controlled trial could be included in the Clinical Studies section of product labeling.
The FDA has designated rexlemestrocel-L as a Regenerative Medicine Advanced Therapy (RMAT) for the treatment of chronic low back pain. This designation provides all the benefits of Breakthrough and Fast Track programs, including rolling review and eligibility for priority review upon filing of a Biologics License Application.
MSB.AX was trading at A$2.57, reflecting a decline of 0.07 points or 2.65%.
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