Mesoblast shares were in focus Monday after the company announced positive formal feedback from the U.S. Food and Drug Administration (FDA) regarding its allogeneic cell therapy, rexlemestrocel-L.
The regulator’s guidance provides a definitive framework for a Biologics License Application (BLA) in the treatment of chronic discogenic low back pain (CLBP), a condition affecting millions with few non-surgical options.
Following a Type B meeting, the FDA acknowledged that results from the first Phase 3 trial (MSB-DR003) showed pain-intensity outcomes that "favor" rexlemestrocel-L over placebo.
Crucially, the agency confirmed that a clinically meaningful reduction in pain at the 12-month mark is an acceptable primary endpoint to support the product's efficacy for approval.
The agency also opened the door for a significant commercial differentiator: opioid stewardship.
The FDA indicated that if a second "adequate and well-controlled" trial demonstrates robust results, data regarding the reduction or cessation of opioid use could be included in the product's official labeling.
In previous analyses, patients treated with the cell therapy showed a three-fold higher rate of opioid cessation compared to controls at 36 months.