Mesoblast Submits FDA Feedback for rexlemestrocel-L Application

Mesoblast provided feedback received from the U.S. Food & Drug Administration, FDA, on 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 follows FDA's Type B meeting review of data from Mesoblast's first randomized controlled Phase 3 trial, MSB-DR003, on pain reduction and relationship to decreased use or elimination of opioids for up to three years following a single rexlemestrocel-L administration. Mesoblast is seeking FDA approval for rexlemestrocel-L based on reduction in CLBP through 12 months. Comparing outcomes between rexlemestrocel-L and placebo from MSB-DR003 trial, FDA acknowledged that the effects on pain intensity appear to favor the active arm. FDA also confirmed that a clinically meaningful reduction in pain intensity in the active arm versus placebo at 12 months can support product efficacy and stated 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.